Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2939388

FEI Number

2939388

Entity Name

SW Technologies Inc.

City/State/Country

UNION CITY, CA, US

Establishment Address

33278 CENTRAL AVE.,, SUITE 102, UNION CITY, CA 94587, US

Establishment Type(s)

Manufacture Medical Device

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

K011044

PMA Number

N/A

All Registered Proprietary Names

Nitrile Exam Glove POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIMS GREEN COLOR Nitrile Exam Gloves TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM Latex Surgeon Gloves PF Nitrile Exam Glove with pH Coating White-Black Color Sleeve, Latex Sterile exam Radiation Radiation Attenuation Sleeve Latex Exam POWDER-FREE HYPOALLERGENIC NITRILE EXAMINATION GLOVES Biodegradable Powder Free Nitrile Examination Glove, TPE POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA @PH 5.5 AND PROTEIN LABELING CLAIMS Biodegradable Powder Free Nitroprene Examination Glove 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 Gloves LATEX GLOVES NITRILE POWDER-FREE EXAMINATION GLOVES Powerform S12+ Nitrile Exam Gloves Megaman Nitrile Exam Gloves, Blue POWDER FREE NITRILE Powerform (PF-065-090-ECO-BK) PowderFree Black Nitrile Exam Gloves Stellar S6 Nitrile Exam Gloves TEXTURED POWER FREE BP2000 (BUTADIENE POLYMER) EXAM GLOVES NATURAL COLOR Vinyl Gloves LATEX GLOVES Latex Gloves

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	2021-04-06
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	2013-12-30
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2012-04-03
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
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2014-05-15
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	2021-04-06
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2021-04-06
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2018-07-13
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
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	2019-07-03
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	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	2013-12-30
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2010-04-09
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2013-12-30
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2007-12-03

Official Correspondent

BELLE CHOU

US Agent Details

No US Agent registered (Local establishment).

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
1000254914	ZHANGJIAGANG DAYU RUBBER PRODUCTS CO., LTD.	ZHANGJIAGANG CITY Jiangsu, CN

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 2939388. Last updated year: 2026. Please use registration number 2939388 when referencing this establishment in official correspondence.