Chrysalis Intelligence · Sponsors · Shen Wei USA, Inc.

Shen Wei USA, Inc.

Union City, CA, US · 13 510(k) clearances

Total clearances
13
2021-03-05 → 2022-05-28
Last 12 months
0
Product codes
3
Most recent
2022-05-28
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
LZA 11 2022-05-28
LYZ 1 2021-12-22
LYY 1 2021-08-19
Filings

All 510(k) clearances (13)

Date K-number Device Code Class Specialty
2022-05-28 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 LZA
2022-01-28 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 LZA
2021-12-22 K213144 Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors LYZ
2021-08-19 K211620 Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less) LYY
2021-07-28 K211455 Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors LZA
2021-06-21 K202085 Biodegradable Powder Free Neoprene Examination Glove, Low Dermatitis Potential Claim, Green LZA
2021-03-25 K202083 Biodegradable Powder Free Nitrile Examination Glove, Blue-White Color with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs LZA
2021-03-24 K202080 Biodegradable Powder Free Nitroprene Examination Glove, Low Dermatitis Potential Claim, Teal-Black Color LZA
2021-03-19 K202081 Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, Blue LZA
2021-03-17 K202082 Biodegradable Powder Free Nitrile Examination Glove, Green-White and Orange-White Colors with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid LZA
2021-03-16 K202086 Biodegradable Powder Free Nitrile Examination Glove, Low Dermatitis,Potential Claim, Blue, Green, Black, White, Orange, Black-White, Teal-Gray, White-Green, White-Orange, White-Blue, Blue-White, Green-White, Orange-White Colors LZA
2021-03-05 K202078 Biodegradable Thermoplastic Elastomer Examination (TPE) Glove LZA
2021-03-05 K202076 Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors LZA