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Bioshield and Universal Latex Exam Gloves

by Dah Lee Rubber Industries (Thai), Ltd. 510(k)

Active United States

510(k) K891268

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK891268 Date22 Aug 1989ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
LYY
FDA applicant
Dah Lee Rubber Industries (Thai) , Ltd.
Device Class
Class I
Regulation
21 CFR Part 880.6250
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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