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FDA 510(k)

LATEX PATIENT EXAMINATION GLOVES

K-Number: K895642 · 1989-12-05

ApplicantSiam Sempermed Corp., Ltd.
Decision Date1989-12-05
Product CodeOPE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LATEX PATIENT EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Siam Sempermed Corp., Ltd.. It received FDA 510(k) clearance on 1989-12-05 under 510(k) number K895642. The device is classified under product code OPE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LATEX PATIENT EXAMINATION GLOVES?

LATEX PATIENT EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 1989-12-05. The listed applicant is Siam Sempermed Corp., Ltd.. The 510(k) number is K895642.

When did LATEX PATIENT EXAMINATION GLOVES receive FDA 510(k) clearance?

LATEX PATIENT EXAMINATION GLOVES received FDA 510(k) clearance on 1989-12-05, under 510(k) number K895642.

Who is the listed applicant for LATEX PATIENT EXAMINATION GLOVES?

The FDA 510(k) record lists Siam Sempermed Corp., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LATEX PATIENT EXAMINATION GLOVES?

The FDA product code for LATEX PATIENT EXAMINATION GLOVES is OPE.

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Other records listing Siam Sempermed Corp., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K121549NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUEK122363NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUEK100907NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) MODEL: WHITE: X-SMALL, SMALLK082957NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLOR, POLYMER COATED, TESTED WITH CHEMOTHERAPY DRUGSK083755NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, LAVENDER BLUE COLOR, POLYMER COATED, TEXTED WITH CHEMOTHERAPY DRUGSK081911NON-STERILE, POWDERED NITRILE EXAMINATION GLOVE, BLUE

View all 36 devices →

Related Devices (Code: OPE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K052845B-CARE POWDERED LATEX EXAMINATION GLOVESB-Care Industries Co., Ltd.K944778LATEX EXAMINATION GLOVESPt. Haloni Jane

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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