FDA 510(k) Premarket Notification K894569: MEDPRIDE LATEX EXAMINATION GLOVES

Submission Details & Decision

Normalized public record details for 510(k) notification K894569.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K894569

Applicant / Sponsor

Transcorp

Device Name

MEDPRIDE LATEX EXAMINATION GLOVES

Product Code

LYY

Decision Date

1989-08-24

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

General Hospital (HO)

Clearance Type

Traditional

Third Party Flag

Date Received

1989-07-21

Related Establishments / Registrations

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SRI TRANG GLOVES (THAILAND) PUBLIC COMPANY LIMITED. Registration: 1000266564 View Registration
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VIRGINIA INDUSTRIES FOR THE BLIND Registration: 1119294 View Registration
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PRIMUS GLOVES PRIVATE LTD. Registration: 3003529075 View Registration
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LIFE SCIENCE PRODUCTS, INC. Registration: 3003823770 View Registration
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PERUSAHAAN GETAH ASAS SDN. BHD. Registration: 3004553390 View Registration
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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
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VANDA GLOVE Registration: 3006979699 View Registration
Molnlycke Health Care AB Registration: 3007048057 View Registration
IMS, INC. Registration: 3007421906 View Registration
PT. UNIVERSAL GLOVES Registration: 3007471500 View Registration
The Cannon Group Inc Registration: 3007502227 View Registration
SHANDONG HUAYUE GLOVE CO., LTD. Registration: 3007707004 View Registration
PACEWELL ASIA SDN. BHD. Registration: 3007791481 View Registration
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CENTRAL MEDICARE SDN BHD Registration: 3008253024 View Registration
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TRUE GLOVE FACTORY Registration: 3009055041 View Registration
PAMITEX INC LIMITED Registration: 3009229300 View Registration
QUBE MEDICAL PRODUCTS SDN BHD Registration: 3009474977 View Registration
ALCATRON GLOVES FACTORY Registration: 3009496643 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.