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FDA 510(k)

POWDER FREE LATEX EXAMINATION GLOVES, PEPPERMINT SCENTED (CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN GR

K-Number: K000867 · 2000-04-21

ApplicantSgmp Co., Ltd.
Decision Date2000-04-21
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POWDER FREE LATEX EXAMINATION GLOVES, PEPPERMINT SCENTED (CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN GR 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 2000-04-21 under 510(k) number K000867. 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 POWDER FREE LATEX EXAMINATION GLOVES, PEPPERMINT SCENTED (CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN GR?

POWDER FREE LATEX EXAMINATION GLOVES, PEPPERMINT SCENTED (CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN GR is a medical device that received FDA 510(k) clearance on 2000-04-21. The listed applicant is Sgmp Co., Ltd.. The 510(k) number is K000867.

When did POWDER FREE LATEX EXAMINATION GLOVES, PEPPERMINT SCENTED (CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN GR receive FDA 510(k) clearance?

POWDER FREE LATEX EXAMINATION GLOVES, PEPPERMINT SCENTED (CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN GR received FDA 510(k) clearance on 2000-04-21, under 510(k) number K000867.

Who is the listed applicant for POWDER FREE LATEX EXAMINATION GLOVES, PEPPERMINT SCENTED (CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN GR?

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 POWDER FREE LATEX EXAMINATION GLOVES, PEPPERMINT SCENTED (CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN GR?

The FDA product code for POWDER FREE LATEX EXAMINATION GLOVES, PEPPERMINT SCENTED (CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN GR is LYY.

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Other records listing Sgmp Co., 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.

K112693NON-STERILE, POWER FREE YELLOW LATEX EXAMINATION GLOVESK101822NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGSK101646NON-STERILE, POWDER FREE BLACK NITRILE EXAMINATION GLOVES WITH CHERRY FLAVORK072403NON-STERILE, POWDERED, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (200 UG OR LESS)K072400NON-STERILE, POWDER-FREE, BLACK NITRILE EXAMINATION GLOVESK072406NON-STERILE, POWDER FREE, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (50 UG OR LESS)

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Related Devices (Code: LYY)

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.

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 LimitedK230573Powder 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 BhdK223298Sterile 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.

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