Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000254914

FEI Number

1000254914

Entity Name

ZHANGJIAGANG DAYU RUBBER PRODUCTS CO., LTD.

City/State/Country

ZHANGJIAGANG CITY Jiangsu, CN

Establishment Address

NO.183 SHUANGLONG ROAD FENGHUANG TOWN, ZHANGJIAGANG CITY Jiangsu 215614, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SW TECHNOLOGIES INC. (Owner Number: 2939388)

Owner / Operator Contact Address

33278 CENTRAL AVE.,, SUITE 102, Union City, CA 94587, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Latex Gloves NITRILE POWDER-FREE EXAMINATION GLOVES Powerform S12+ Nitrile Exam Gloves Megaman Nitrile Exam Gloves, Blue Powerform Nitrile Gloves Dritek Ecotek, Gray Megaman Nitrile Gloves Dritek Ecotek, Black POWDER FREE NITRILE Powerform (PF-065-090-ECO-BK) PowderFree Black Nitrile Exam Gloves Stellar S6 Nitrile Exam Gloves LATEX GLOVES Panther Guard Nitrile Exam Gloves nitrile exam glove Nitrile Exam Gloves Latex Gloves POWDER-FREE BUTADIENE COPOLYMER EXAM GLOVES WITH ALOE VITAMINS E PH5.5 PATIENT EXAMINATION GLOVES (LATEX) Aloeform X6 Nitrile Exam Gloves Aloeform Soft Nitrile Exam Gloves Fisher 19-050-550X Nitrile Exam Gloves Aloetuff Nitrile Exam Gloves NITRILE EXAM GLOVES Medline Professional Nitrile Exam Gloves Trueform Nitrile Exam Gloves TF-95RB Powerform Nitrile Exam Gloves PF-12TL Powerform Nitrile Exam Gloves PF-95TL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIMS GREEN COLOR POWDER FREE BUTADIENE Biodegradable Powder Free Nitrile Examination Glove, APEXPRO Powder Free Nitrile Exam TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM Atlantic Safety-Black Lightning Nitrile Exam Gloves NITRILE EXAM GLOVES LATEX GLOVES Biodegradable DriTek Powder Free Nitrile Examination Glove Latex Gloves FLock-Lined Nitrile Exam Glove Powder Free Megaman Absorbent Lined Exam Glove Global Glove 800F Powerform (PF-088-095-DRK/ECO-GY) Flocklined Nitrile Exam Glove Global Glove 600F LATEX POWDER FREE Bantam TPE Exam Gloves Poweform Nitrile Exam PF-085-095-DCO-BL NITRILE EXAM GLOVES Hydrex Nitrile Exam Gloves LATEX EXAM GLOVES Biodegradable Powder Free Nitroprene Examination Glove TEXTURED POWER FREE BP2000 (BUTADIENE POLYMER) EXAM GLOVES NATURAL COLOR Powerform (PF-088-095-LB) Powder-Free Nitrile Exam Glove PowerForm (PF-065-095-ECO-TL) Powder Free Nitrile Exam Glove nitrile gloves Nitrile Gloves PF Nitrile Exam Glove with pH Coating White-Black Color POWDER-FREE NITRILE EXAM GLOVES Indigo Nitrile Exam Glove Latex Gloves Nitrile Gloves Latex Gloves

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2010-05-14
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2013-12-30
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2021-03-08
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2007-12-03
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2013-12-30
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2021-07-29
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2018-07-13
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2018-07-13
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2021-04-06
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2007-12-03
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2013-12-30
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2013-12-30
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2007-12-03
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2022-06-01
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2013-12-30
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2007-12-03
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2021-04-06
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2021-04-06
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2020-03-30
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2020-03-30
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2020-03-30
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2007-12-12
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2013-12-30
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2009-09-02
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2013-12-30
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2021-04-06
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2007-11-30
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2016-12-29
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2007-12-03
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2021-03-08
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2006-07-17
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2006-07-17
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2021-04-06
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2013-12-30
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2007-11-30
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2012-12-17
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2017-06-01
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2017-06-01
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2005-11-14
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2007-11-30
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2010-01-29

Official Correspondent

BELLE CHOU

US Agent Details

BELLE CHOU Email: qa@swssglobal.com Phone: (510) 4298692

Related Public Records

Same Entity

SW TECHNOLOGIES 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
2939388	SW Technologies Inc.	UNION CITY, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K894452	Kerala Rubber & Reclaims, Ltd.	KRR GLOVE, PATIENT EXAMINATION GLOVES	1989-08-09
K891323	Li Wah-Hong Kong, Inc.	LI WAH LATEX EXAMINATION GLOVES	1989-08-31
K891418	C & K Mfg. & Sales Co.	LATEX EXAMINATION GLOVES, STYLE 510 LX	1989-06-22
K994255	Pt. Maja Agung Latexindo	LATEX EXAMINATION GLOVES-PRE-POWDERED-STERILE	2000-02-07
K892946	Yeou-Fwu Rubber Industrial Co., Ltd.	STERILE PATIENT EXAMINATION GLOVES	1989-08-10

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000254914. Last updated year: 2026. Please use registration number 1000254914 when referencing this establishment in official correspondence.