FDA 510(k)

SURGEON'S GLOVE, POWDER FREE

K-Number: K052030 · 2005-09-13

ApplicantShun Thai Rubber Gloves Industry Public Co., Ltd.

Decision Date2005-09-13

Product CodeKGO

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

SURGEON'S GLOVE, POWDER FREE is the device name listed in this FDA 510(k) record. The listed applicant is Shun Thai Rubber Gloves Industry Public Co., Ltd.. It received FDA 510(k) clearance on 2005-09-13 under 510(k) number K052030. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGEON'S GLOVE, POWDER FREE?

SURGEON'S GLOVE, POWDER FREE is a medical device that received FDA 510(k) clearance on 2005-09-13. The listed applicant is Shun Thai Rubber Gloves Industry Public Co., Ltd.. The 510(k) number is K052030.

When did SURGEON'S GLOVE, POWDER FREE receive FDA 510(k) clearance?

SURGEON'S GLOVE, POWDER FREE received FDA 510(k) clearance on 2005-09-13, under 510(k) number K052030.

Who is the listed applicant for SURGEON'S GLOVE, POWDER FREE?

The FDA 510(k) record lists Shun Thai Rubber Gloves Industry Public Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGEON'S GLOVE, POWDER FREE?

The FDA product code for SURGEON'S GLOVE, POWDER FREE is KGO.

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Other records listing Shun Thai Rubber Gloves Industry Public Co., Ltd. as applicant

K092617ROYAL GUARD K060229POWDER-FREE BLACK LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTE K052031POWDERED LATEX SURGEON'S GLOVE K040406POLYMER COATED, CHLORINATED, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (LESS THAN 50 UG/G PER GLOVE)K040408POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (LESS THAN 50 UG/G PER GLOVE)

Related Devices (Code: KGO)

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Official Source

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