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Found 2 results

510(k) Data Aggregation

K Number

Device Name

STERILE POWDER FREE SYNTHETIC SURGICAL GLOVE WITH POLYMER COATING

Manufacturer

P.T. SAPTINDO SURGICA

Date Cleared

2003-09-23

(117 days)

Product Code

Regulation Number

Why did this record match?

Applicant Name (Manufacturer) :

P.T. SAPTINDO SURGICA

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty

Intended Use

A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.

Device Description

Sterile Powder Free Synthetic Surgical Gloves with Polymer Coating

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K Number

Device Name

STERILE POWDER FREE LATEX SURGICAL GLOVE WITH POLYMER COATING

Manufacturer

P.T. SAPTINDO SURGICA

Date Cleared

2003-09-23

(117 days)

Product Code

Regulation Number

Why did this record match?

Applicant Name (Manufacturer) :

P.T. SAPTINDO SURGICA

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty

Intended Use

A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.

Device Description

Sterile Powder Free Latex Surgical Gloves with Polymer Coating

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