510(k) Report

FDA applicant

Amazing Rubber Products Pvt, Ltd.

Cochin, IN4 decisions2022–20220 recalls

FDA records 4 decisions for Amazing Rubber Products Pvt, Ltd. (Cochin, IN) in 2022: 4 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and LYY (Latex Patient Examination Glove). Since 2016 its 510(k)s took a median of 241 days from receipt to decision, against 119 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 Amazing Rubber Products Pvt, Ltd.’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 — Amazing Rubber Products Pvt, Ltd. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • LZAPolymer Patient Examination Glove2decisions
  • LYYLatex Patient Examination Glove1decision
  • KGOSurgeon'S Gloves1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 241 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 119 days; 0 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:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K212596Sterile Latex Surgical Gloves Powder FreeAmazing Rubber Products Pvt, Ltd. · 20221cites it

What has FDA decided for it lately?

  • K212584Blue Nitrile Examination Gloves Powder FreeAmazing Rubber Products Pvt, Ltd. · 2022
  • K212597Amazing+ Latex Examination Powder Free GlovesAmazing Rubber Products Pvt, Ltd. · 2022
  • K212596Sterile Latex Surgical Gloves Powder FreeAmazing Rubber Products Pvt, Ltd. · 2022
  • K212586Amazing+Amazing Rubber Products Pvt, Ltd. · 2022

All 4 as Amazing Rubber Products Pvt, Ltd. →