FDA 510(k) Premarket Notification K892134: PATIENT EXAMINATION GLOVES (LATEX)

Submission Details & Decision

Normalized public record details for 510(k) notification K892134.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K892134

Applicant / Sponsor

Steril Rubber Sdn. Bhd.

Device Name

PATIENT EXAMINATION GLOVES (LATEX)

Product Code

LYY

Decision Date

1989-04-28

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

General Hospital (HO)

Clearance Type

Traditional

Third Party Flag

Date Received

1989-04-04

Related Establishments / Registrations

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DIPPED PRODUCTS (THAILAND) LTD Registration: 3005024094 View Registration
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COMFORT RUBBER GLOVES INDUSTRIES SDN BHD Registration: 3005568780 View Registration
KOSSAN LATEX INDUSTRIES (M) SDN BHD Registration: 3005632797 View Registration
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Molnlycke Health Care AB Registration: 3007048057 View Registration
IMS, INC. Registration: 3007421906 View Registration
PT. UNIVERSAL GLOVES Registration: 3007471500 View Registration
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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 Information may be outdated or incomplete.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.