# Shen Wei (Usa), Inc.

- Location (FDA's records): Union City, CA
- FDA decisions: 58 (1989–2022): 58 510(k) clearances
- Names in FDA's records: Shen Wei (Usa), Inc. (40); Shen Wei USA, Inc. (18)
- Product codes: LZA (34), LYY (14), LYZ (6), LZC (3), KGO (1)
- 510(k) review time since 2016: median 221 days, against 111 for FDA's reviews in the same codes and years (5 of 19 faster)
- Predicates its devices cite: 8 (6 its own); citations of its devices by later devices: 8 (6 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Siam Sempermed Corp., Ltd.: 1 (https://510kreport.com/company/siam-sempermed)
- Shanghai Motex Healthcare Co., Ltd.: 1 (https://510kreport.com/company/shanghai-motex-healthcare)

## Firms that cite its devices most
- Guangdong Kingfa Sci. & Tech.Co., Ltd.: 1 (https://510kreport.com/company/guangdong-kingfa-sci-tech)
- Medline Industries, Inc.: 1 (https://510kreport.com/company/medline-industries)

## Its most-cited devices
- K090194: Powder- Free Nitrile Examination Gloves, Black Color (2009), cited by 2
- K120890: Powder-Free Nitrie Examination Gloves, Orange (2012), cited by 1
- K092411: Pearlescent Powder Free Nitrile Examination Gloves with Aloe Vera (Yellow, Red, Green, Black, Blue) (2009), cited by 1
- K013793: Powder Free Latex Examination Gloves with Aloe Vera @PH 5.5 and Protein Labeling Claims (2002), cited by 1
- K032024: Powder-Free Nitrile Examination Gloves, Blue Color (Tested for  Use with Chemotherapy Drugs) (2003), cited by 1
- K993876: Powder-Free Nitrile Examination Gloves with Aloe Vera (2000), cited by 1

## Recent decisions
- K213141: Biodegradable Powder Free Nitrile Examination Glove, Blue and Green colors, Low Dermatitis Potential, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution (May 28, 2022)
- K213142: Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate Simulated Gastric Acid Solution (Jan 28, 2022)
- K213144: Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors (Dec 22, 2021)
- K211620: Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less) (Aug 19, 2021)
- K211455: Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors (Jul 28, 2021)
- K202085: Biodegradable Powder Free Neoprene Examination Glove, Low Dermatitis Potential Claim, Green (Jun 21, 2021)
- K202083: Biodegradable Powder Free Nitrile Examination Glove, Blue-White Color with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Mar 25, 2021)
- K202080: Biodegradable Powder Free Nitroprene Examination Glove, Low Dermatitis Potential Claim, Teal-Black Color (Mar 24, 2021)

Source page: https://510kreport.com/company/shen-wei-usa