FDA 510(k)

ROYALSHIELD NON-STERILE POWDER-FREE

K-Number: K945031 · 1995-01-11

ApplicantShield Gloves Manufacturer (M) Sdn Bhd

Decision Date1995-01-11

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

ROYALSHIELD NON-STERILE POWDER-FREE is the device name listed in this FDA 510(k) record. The listed applicant is Shield Gloves Manufacturer (M) Sdn Bhd. It received FDA 510(k) clearance on 1995-01-11 under 510(k) number K945031. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROYALSHIELD NON-STERILE POWDER-FREE?

ROYALSHIELD NON-STERILE POWDER-FREE is a medical device that received FDA 510(k) clearance on 1995-01-11. The listed applicant is Shield Gloves Manufacturer (M) Sdn Bhd. The 510(k) number is K945031.

When did ROYALSHIELD NON-STERILE POWDER-FREE receive FDA 510(k) clearance?

ROYALSHIELD NON-STERILE POWDER-FREE received FDA 510(k) clearance on 1995-01-11, under 510(k) number K945031.

Who is the listed applicant for ROYALSHIELD NON-STERILE POWDER-FREE?

The FDA 510(k) record lists Shield Gloves Manufacturer (M) Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROYALSHIELD NON-STERILE POWDER-FREE?

The FDA product code for ROYALSHIELD NON-STERILE POWDER-FREE is LYY.

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Other records listing Shield Gloves Manufacturer (M) Sdn Bhd as applicant

K011613POWDER-FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVE K000217ROYAL SHIELD NON-STERILE PURPLE (PINK/BLUE) COLORED POWDERED LATEX EXAM WITH PROTEIN LABELING CLAIM [<200 MCG OR LESS] W K000156SMART SHIELD NON-STERILE POWDER-FREE PEPPERMINT SCENTED GREEN LATEX EXAMINATION GLOVES K992417ROYAL SHIELD NON-STERILE POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABELING CLAIM) 200 MCGM OR LESS OF TOTAL WATER EXTR K992418ROYAL SHIELD NON-STERILE PINK COLORED POWDERED LATEX EXAMINATION GLOVE WITH AND WITHOUT STRAWBERRY SCENT AND WITH PROTEI K992419ROYAL SHIELD NON-STERILE BLUE COLORED POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MCGM OR

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Related Devices (Code: LYY)

K250069Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less ProteinComfort Rubber Gloves Industries Sdn. Bhd.K240266Latex Examination Glove Powder Free (Ocean Blue and Natural White)Sri Trang Gloves (Thailand) Public Company Limited K230573Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)Kossan International Sdn Bhd K223298Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)Shandong Intco Medical Products Co, Ltd.K222612Powder-Free Latex examination glovesGuangdong Kingfa Sci. & Tech.Co., Ltd.K221667Non Sterile Powder Free Latex Examination GloveNew Era Medicare Sdn. Bhd.

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.