SNA SAFEHEALTH SOLUTIONS INC.

FDA Device Registration & Listing · Monrovia, CA, US · Registration 3034618336

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
3034618336
FEI Number
3034618336
Entity Name
SNA SAFEHEALTH SOLUTIONS INC.
City/State/Country
Monrovia, CA, US
Establishment Address
605 E Huntington Dr Ste 208, Monrovia, CA 91016, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
SNA SafeHealth Solutions Inc. (Owner Number: 10092359)
Owner / Operator Contact Address
605 East Huntington Drive, Suite 208, Monrovia, CA 91016, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

polymer examination glove Polyurethane Film Transparent Dressing; I.V. Catheter Dressing vinyl examination gloves foam dressing; silicone dressing polymer examination glove

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 2024-12-27
KMK Device, Intravascular Catheter Securement General Hospital Class 1 880.5210 2025-04-18
LYZ Vinyl Patient Examination Glove General Hospital Class 1 880.6250 2024-12-27
NAD Dressing, Wound, Occlusive General, Plastic Surgery Class 1 878.4020 2025-04-17
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-12-27
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2024-12-27
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2024-12-27
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2024-12-27

Official Correspondent

Daniel Shi

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SNA SafeHealth Solutions Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0013-2019 COVIDIEN LLC 1
Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019 COVIDIEN LLC 1
Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019 COVIDIEN LLC 1
Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019 COVIDIEN LLC 1
Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019 COVIDIEN LLC 1
Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3034618336. Last updated year: 2026. Please use registration number 3034618336 when referencing this establishment in official correspondence.
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