510(k) Report

FDA applicant

Pan-Century Rubber Products Sdn. Bhd.

81700 Johor, Malaysia, ML9 decisions1989–19990 recalls

FDA records 9 decisions for Pan-Century Rubber Products Sdn. Bhd. (81700 Johor, Malaysia, ML) from 1989 to 1999: 9 510(k) clearances. All are in product code LYY (Latex Patient Examination Glove). 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 Pan-Century Rubber Products Sdn. Bhd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pan-Century Rubber Products Sdn. Bhd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Pan-Century Rubber Products Sdn. Bhd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Pan-Century Rubber Products Sdn. Bhd.’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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Which product codes does it file in?

  • LYYLatex Patient Examination Glove9decisions

What has FDA decided for it lately?

  • K993183Powder Free Gloves (Polymer Coated)Pan-Century Rubber Products Sdn. Bhd. · 1999
  • K993287Powder Free (Silicon Coated) Latex Examination Gloves with Protein Labeling ClaimPan-Century Rubber Products Sdn. Bhd. · 1999
  • K981164Powder Free Chlorinated Gloves-(Textured)Pan-Century Rubber Products Sdn. Bhd. · 1998
  • K955241High Risk GlovesPan-Century Rubber Products Sdn. Bhd. · 1996
  • K924633Hypoallergenic Latex GlovesPan-Century Rubber Products Sdn. Bhd. · 1993
  • K910046Patient Examination Gloves-Anatomical GlovesPan-Century Rubber Products Sdn. Bhd. · 1991
  • K910047Patient Examination Gloves-Textured GlovesPan-Century Rubber Products Sdn. Bhd. · 1991
  • K910045Patient Examination Gloves-Powder FreedPan-Century Rubber Products Sdn. Bhd. · 1991

All 9 as Pan-Century Rubber Products Sdn. Bhd. →