PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs— 510(k) K173766
Substantially EquivalentShen Wei USA, Inc.
FDA 510(k) clearance K173766 for PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs, Substantially Equivalent on 2018-07-08. Applicant: Shen Wei USA, Inc.. Device class: 1.
Clearance details
- Applicant
- Shen Wei USA, Inc.
- Product code
- Code LZC
- Device class
- Class 1
- Regulation
- 21 CFR 880.6250
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Union City, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.