SAFESKIN MEDICAL & SCIENTIFIC (THAILAND), LTD.

FDA Device Registration & Listing · SADAO Songkhla, TH · Registration 9614175

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9614175
FEI Number
1000297006
Entity Name
SAFESKIN MEDICAL & SCIENTIFIC (THAILAND), LTD.
City/State/Country
SADAO Songkhla, TH
Establishment Address
200 MOO 8 KANCHANAVANICH ROAD, TAMBOL PRIK, SADAO Songkhla 90120, TH
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
O&M Halyard, Inc. (Owner Number: 10057479)
Owner / Operator Contact Address
1220 Old Alpharetta Rd, Suite 320, Alpharetta, GA 30005, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K241909
PMA Number
N/A

All Registered Proprietary Names

POLYMER PATIENT EXAM GLOVE Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove K160709 Halyard STERLING SG* SENSI-GUARD Powder-Free Nitrile Exam Gloves Halyard STERLING NITRILE-XTRA * Powder-Free Exam Gloves SAFESKIN NITRILE EXAM GLOVE Halyard STERLING* Powder-Free Nitrile Exam Gloves POLYMER PATIENT EXAM GLOVE POLYMER PATIENT EXAM GLOVE EXAMINATION GLOVE, SPECIALTY POLYMER PATIENT EXAMINATION GLOVE POLYMER PATIENT EXAM GLOVE POLYMER PATIENT EXAMINATION GLOVE Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gast PureZero MARIN Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim Halyard Purple Nitrile Max Powder-Free Exam Gloves Fusion Black Powder-Free Nitrile Exam Glove SkyBreeze Zero Nitrile Powder-Free Exam Glove Halyard Lavender Nitrile Powder-Free Exam Gloves PURPLE NITRILE-XTRA* Sterile Powder-Free Exam Gloves PureZero LIMON Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim POLYMER PATIENT EXAMINATION GLOVE Sterling Nitrile Powder-Free Exam Gloves Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested For Use With Chemotherapy Drugs And And Fenta Halyard Purple Nitrile* Powder-Free Exam Gloves Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fenta

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2018-05-02
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2021-06-29
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2021-06-29
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2021-06-29
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2018-05-02
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-03-25
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2024-03-25
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2024-03-25
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2024-03-25
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2018-05-02
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-12-11
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-12-11
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2025-12-11
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2025-12-11
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2018-05-02
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2018-05-02
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2018-05-02
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2018-05-02
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2018-06-28
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2018-06-28
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2018-05-02
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2018-05-02
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2018-05-02
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2018-05-02
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2022-08-03
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2022-08-03
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2022-08-03
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2022-06-03
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2022-06-03
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2022-06-03
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2020-01-09
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2020-01-09
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2023-12-01
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2020-01-09
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2020-01-09
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2022-08-22
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2022-08-22
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2022-08-22
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2021-01-14
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2021-01-14
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2021-01-14
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2022-06-03
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2022-06-03
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2022-06-03
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2018-05-02
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2020-01-09
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2021-02-19
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2021-02-19
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2021-02-19
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2025-01-28
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2025-01-28
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-01-28
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-01-28

Official Correspondent

Angela Bunn

US Agent Details

Angela Bunn Business: O&M HALYARD, INC. Email: angela.bunn@owens-minor.com Phone: (470) 3647147

Related Public Records

Same Entity

O&M Halyard, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3012143814 Southaven Distribution Center Southaven, MS, US
3016849443 O&M Halyard, Inc. (La Ada de Acuna) Del Rio, TX, US
1054380 Halyard North Carolina, LLC LINWOOD, NC, US
9680646 O&M Halyard Honduras S.A de C.V. VILLANEVA Cortes, HN
3035642068 Honduras Kitting, S.A. Villanueva Cortes, HN

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K212801 Hong Seng Gloves Sdn Bhd Powder free nitrile examination glove- black, non sterile 2022-01-09
K260806 Vista Industries,, LLC Nitrile Disposable Examination Gloves 2026-06-03
K011593 Ansell Healthcare Products, Inc. MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE 2001-06-21
K981039 Sri Johani Sdn. Bhd. POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED) 1998-04-21
K101595 Better Care Plastic Technology Cp., Ltd. POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE 2010-08-06

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9614175. Last updated year: 2026. Please use registration number 9614175 when referencing this establishment in official correspondence.
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