FDA 510(k)

NON-STERILE, POWER FREE YELLOW LATEX EXAMINATION GLOVES

K-Number: K112693 · 2012-09-12

Decision Date2012-09-12

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

NON-STERILE, POWER FREE YELLOW LATEX EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Sgmp Co., Ltd.. It received FDA 510(k) clearance on 2012-09-12 under 510(k) number K112693. 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 NON-STERILE, POWER FREE YELLOW LATEX EXAMINATION GLOVES?

NON-STERILE, POWER FREE YELLOW LATEX EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 2012-09-12. The listed applicant is Sgmp Co., Ltd.. The 510(k) number is K112693.

When did NON-STERILE, POWER FREE YELLOW LATEX EXAMINATION GLOVES receive FDA 510(k) clearance?

NON-STERILE, POWER FREE YELLOW LATEX EXAMINATION GLOVES received FDA 510(k) clearance on 2012-09-12, under 510(k) number K112693.

Who is the listed applicant for NON-STERILE, POWER FREE YELLOW LATEX EXAMINATION GLOVES?

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

What is the FDA product code for NON-STERILE, POWER FREE YELLOW LATEX EXAMINATION GLOVES?

The FDA product code for NON-STERILE, POWER FREE YELLOW LATEX EXAMINATION GLOVES is LYY.

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Other records listing Sgmp Co., Ltd. as applicant

K101822NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS K101646NON-STERILE, POWDER FREE BLACK NITRILE EXAMINATION GLOVES WITH CHERRY FLAVOR K072403NON-STERILE, POWDERED, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (200 UG OR LESS)K072400NON-STERILE, POWDER-FREE, BLACK NITRILE EXAMINATION GLOVES K072406NON-STERILE, POWDER FREE, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (50 UG OR LESS)K071060NON-STERILE, LATEX POWDER FREE PATIENT EXAMINATION GLOVES (MULTICOLORED WITH XYLITOL AND CALCIUM CARBONATE)

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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.