FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
Biodegradable Powder Free Nitrile Examination Glove, Blue-White Color with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs
K Number: K202083
·
Decision Mar 25, 2021
Classifications
1
FEI Numbers
380
Registration Numbers
380
Same Product Code
1171
Applicant Total
18
Review Days
241
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Basic Information
- Device Name
- Biodegradable Powder Free Nitrile Examination Glove, Blue-White Color with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs
- K Number
- K202083
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Shen Wei USA, Inc.
- Date Received
- July 27, 2020
- Decision Date
- March 25, 2021
- Product Code
- LZA
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | FDA class 1 | General Hospital |
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Other Clearances by Shen Wei USA, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 | Substantially Equivalent |
| 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 | Substantially Equivalent |
| K213144 | Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors | Dec 22, 2021 | Substantially Equivalent |
| 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 | Substantially Equivalent |
| K211455 | Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors | Jul 28, 2021 | Substantially Equivalent |
| K202085 | Biodegradable Powder Free Neoprene Examination Glove, Low Dermatitis Potential Claim, Green | Jun 21, 2021 | Substantially Equivalent |
| K202080 | Biodegradable Powder Free Nitroprene Examination Glove, Low Dermatitis Potential Claim, Teal-Black Color | Mar 24, 2021 | Substantially Equivalent |
| K202081 | Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, Blue | Mar 19, 2021 | Substantially Equivalent |
| 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 | Mar 17, 2021 | Substantially Equivalent |
| 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 | Mar 16, 2021 | Substantially Equivalent |