FDA 510(k) Premarket Notification K891323: LI WAH LATEX EXAMINATION GLOVES

Submission Details & Decision

Normalized public record details for 510(k) notification K891323.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K891323

Applicant / Sponsor

Li Wah-Hong Kong, Inc.

Device Name

LI WAH LATEX EXAMINATION GLOVES

Product Code

LYY

Decision Date

1989-08-31

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

General Hospital (HO)

Clearance Type

Traditional

Third Party Flag

Date Received

1989-03-13

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This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.