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FDA 510(k)

CLK INT'L POWDER FREE LATEX EXAMINATION GLOVE

K-Number: K974371 · 1998-04-21

ApplicantClk Intl., Inc.
Decision Date1998-04-21
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CLK INT'L POWDER FREE LATEX EXAMINATION GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Clk Intl., Inc.. It received FDA 510(k) clearance on 1998-04-21 under 510(k) number K974371. 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 CLK INT'L POWDER FREE LATEX EXAMINATION GLOVE?

CLK INT'L POWDER FREE LATEX EXAMINATION GLOVE is a medical device that received FDA 510(k) clearance on 1998-04-21. The listed applicant is Clk Intl., Inc.. The 510(k) number is K974371.

When did CLK INT'L POWDER FREE LATEX EXAMINATION GLOVE receive FDA 510(k) clearance?

CLK INT'L POWDER FREE LATEX EXAMINATION GLOVE received FDA 510(k) clearance on 1998-04-21, under 510(k) number K974371.

Who is the listed applicant for CLK INT'L POWDER FREE LATEX EXAMINATION GLOVE?

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

What is the FDA product code for CLK INT'L POWDER FREE LATEX EXAMINATION GLOVE?

The FDA product code for CLK INT'L POWDER FREE LATEX EXAMINATION GLOVE is LYY.

Related Clinical Trials

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.

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Other records listing Clk Intl., 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.

K974301CLK INT'L. SANITARY LATEX PROBE COVER, CLK ULTRASOUND PROBE COVER

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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