Black Nitrile Powder Free Patient Examination Glove, Non Sterile— 510(k) K222715

Substantially Equivalent

Safeskin Retailing (Hk) Limited

FDA 510(k) clearance K222715 for Black Nitrile Powder Free Patient Examination Glove, Non Sterile, Substantially Equivalent on 2022-12-03. Applicant: Safeskin Retailing (Hk) Limited. Device class: 1.

Clearance details

Applicant
Safeskin Retailing (Hk) Limited
Product code
Code LZA
Device class
Class 1
Regulation
21 CFR 880.6250
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Hong Kong, CN
Download summary PDFView on FDA.gov ↗

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Adverse events under product code LZA

product code LZA
Other
1
Total
1

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.