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FDA 510(k)

SMART - GLOVE POWDER FREE LATEX EXAMINATION GLOVE

K-Number: K971403 · 1997-05-29

ApplicantSj Medical Products (M) Sdn Bhd
Decision Date1997-05-29
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SMART - GLOVE POWDER FREE LATEX EXAMINATION GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Sj Medical Products (M) Sdn Bhd. It received FDA 510(k) clearance on 1997-05-29 under 510(k) number K971403. 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 SMART - GLOVE POWDER FREE LATEX EXAMINATION GLOVE?

SMART - GLOVE POWDER FREE LATEX EXAMINATION GLOVE is a medical device that received FDA 510(k) clearance on 1997-05-29. The listed applicant is Sj Medical Products (M) Sdn Bhd. The 510(k) number is K971403.

When did SMART - GLOVE POWDER FREE LATEX EXAMINATION GLOVE receive FDA 510(k) clearance?

SMART - GLOVE POWDER FREE LATEX EXAMINATION GLOVE received FDA 510(k) clearance on 1997-05-29, under 510(k) number K971403.

Who is the listed applicant for SMART - GLOVE POWDER FREE LATEX EXAMINATION GLOVE?

The FDA 510(k) record lists Sj Medical Products (M) Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMART - GLOVE POWDER FREE LATEX EXAMINATION GLOVE?

The FDA product code for SMART - GLOVE POWDER FREE LATEX EXAMINATION GLOVE is LYY.

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Other records listing Sj Medical Products (M) Sdn Bhd 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.

K971666SMART - FIT, PREPOWDERED NITRILE EXAMINATION GLOVESK971665SMART - FIT, POWDERFREE NITRILE EXAMINATION GLOVESK941754POWDER FREE LATEX EXMINATION GLOVESK932332PATIENT EXAMINATION GLOVE - POWDERED

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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