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510(k) Data Aggregation

K Number

Device Name

PRE-POWDERED LATEX ORTHOPEDIC SURGEON'S GLOVES

Manufacturer

PRIMUS GLOVES PRIVATE LTD.

Date Cleared

2003-06-05

(114 days)

Product Code

Regulation Number

Type

Panel

General Hospital

Reference & Predicate Devices

N/A

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N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

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