510(k) Report

FDA applicant

Protect Gloves Co., Ltd.

Pluakdang, TH2 decisions2022–20260 recalls

FDA records 2 decisions for Protect Gloves Co., Ltd. (Pluakdang, TH) from 2022 to 2026: 2 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and KGO (Surgeon'S Gloves). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Protect Gloves Company Limited”.

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 Protect Gloves Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2022: 12026 (partial year): 1
2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Protect Gloves Co., Ltd. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Protect Gloves Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Protect”

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