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FDA 510(k)

SKINGARD POLYCOAT GLOVE

K-Number: K004018 · 2001-05-11

ApplicantTop Quality Mfg., Inc.
Decision Date2001-05-11
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SKINGARD POLYCOAT GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Top Quality Mfg., Inc.. It received FDA 510(k) clearance on 2001-05-11 under 510(k) number K004018. 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 SKINGARD POLYCOAT GLOVE?

SKINGARD POLYCOAT GLOVE is a medical device that received FDA 510(k) clearance on 2001-05-11. The listed applicant is Top Quality Mfg., Inc.. The 510(k) number is K004018.

When did SKINGARD POLYCOAT GLOVE receive FDA 510(k) clearance?

SKINGARD POLYCOAT GLOVE received FDA 510(k) clearance on 2001-05-11, under 510(k) number K004018.

Who is the listed applicant for SKINGARD POLYCOAT GLOVE?

The FDA 510(k) record lists Top Quality Mfg., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SKINGARD POLYCOAT GLOVE?

The FDA product code for SKINGARD POLYCOAT GLOVE is LYY.

Related Clinical Trials

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Other records listing Top Quality Mfg., Inc. 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.

K013821SILK TOUCH POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)K013254POLYCOAT POWDERED LATEX EXAMINATION GLOVE WITH ALOE VERA & PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)K000050TOP QUALITY CHLORINATED-POWDERFREE EXAMINATION GLOVES

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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