FDA 510(k)

ROYAL GUARD

K-Number: K092617 · 2010-05-20

ApplicantShun Thai Rubber Gloves Industry Public Co., Ltd.

Decision Date2010-05-20

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

ROYAL GUARD 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 2010-05-20 under 510(k) number K092617. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROYAL GUARD?

ROYAL GUARD is a medical device that received FDA 510(k) clearance on 2010-05-20. The listed applicant is Shun Thai Rubber Gloves Industry Public Co., Ltd.. The 510(k) number is K092617.

When did ROYAL GUARD receive FDA 510(k) clearance?

ROYAL GUARD received FDA 510(k) clearance on 2010-05-20, under 510(k) number K092617.

Who is the listed applicant for ROYAL GUARD?

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 ROYAL GUARD?

The FDA product code for ROYAL GUARD is LZA.

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

K060229POWDER-FREE BLACK LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTE K052030SURGEON'S GLOVE, POWDER FREE 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: LZA)

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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.