510(k) Report

FDA applicant

American Seal Co.

Hayward, CA6 decisions1989–19971 recall

FDA records 6 decisions for American Seal Co. (Hayward, CA) from 1989 to 1997: 6 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and KKX (Drape, Surgical, Antimicrobial). 1 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 and plastic surgery panel, where it files most

How often FDA has decided American Seal Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for American Seal Co. since 2007.

Recalls per year

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — American Seal Co. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LYYLatex Patient Examination Glove2decisions
  • KKXDrape, Surgical, Antimicrobial1decision
  • FXXMask, Surgical1decision
  • FYCGown, Isolation, Surgical1decision
  • FYFCap, Surgical1decision

What has FDA decided for it lately?

  • K972187Bouffant CapAmerican Seal Co. · 1997
  • K972227Shoe CoverAmerican Seal Co. · 1997
  • K970814Non-Sterile Isolation GownAmerican Seal Co. · 1997
  • K964358Amseal Surgical Face MaskAmerican Seal Co. · 19971 recall
  • K892557Maytex Non-Sterile Latex Exam GloveAmerican Seal Co. · 1989
  • K892553Maytex Patient Examination GlovesAmerican Seal Co. · 1989

All 6 as American Seal Co. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K964358Comfort brand Ear-Loop Face Mask, Item #: 3100, Model Numbers: # 3100B, # 3100P, #…May 15, 2013Class II