510(k) Report

FDA applicant

S&S Glove Corporation

Ba Ria-Vung Tau, VN3 decisions2023–20260 recalls

FDA records 3 decisions for S&S Glove Corporation (Ba Ria-Vung Tau, VN) from 2023 to 2026: 3 510(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 92 for FDA’s reviews in the same codes and years. Its devices cite 1 predicate, 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 S&S Glove Corporation’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2023: 22026 (partial year): 1
2023high 2 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — S&S Glove Corporation by year, 2023–2026Sources: 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 Glove3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(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 92 days; 3 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K260703Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl;Powder Free…S&S Glove Corporation · 2026
  • K231439Powder Free White, Black, and Purple Nitrile Examination GloveS&S Glove Corporation · 2023
  • K223444Powder Free Blue Nitrile Examination GloveS&S Glove Corporation · 2023

All 3 as S&S Glove Corporation →