510(k) Report

FDA applicant

Safeskin Retailing (Hk) Limited

Hong Kong, CN4 decisions2022–20220 recalls

FDA records 4 decisions for Safeskin Retailing (Hk) Limited (Hong Kong, CN) in 2022: 4 510(k) clearances. All are in product code LZA (Polymer Patient Examination Glove). Since 2016 its 510(k)s took a median of 86 days from receipt to decision, against 111 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Safeskin Retailing (Hk) Limited’s devices, and how often a recall has named them.

FDA decisions per year

4in 2022

2022: 4
2022high 4 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Safeskin Retailing (Hk) Limited by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LZAPolymer Patient Examination Glove4decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 86 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 111 days; 4 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K222713White Nitrile Powder Free Patient Examination Glove, Non SterileSafeskin Retailing (Hk) Limited · 2022
  • K222720Blue Nitrile Powder Free Patient Examination Glove, Non SterileSafeskin Retailing (Hk) Limited · 2022
  • K222715Black Nitrile Powder Free Patient Examination Glove, Non SterileSafeskin Retailing (Hk) Limited · 2022
  • K222721Violet Nitrile Powder Free Patient Examination Glove, Non SterileSafeskin Retailing (Hk) Limited · 2022

All 4 as Safeskin Retailing (Hk) Limited →

Other applicant names beginning “Safeskin”

FDA records each applicant name separately; these may or may not be the same firm.

Safeskin Corp. 24