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FDA 510(k)

HEALTH-PLUS, SANITEX, RELIANCE, BLUE PRE-POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (100 MIC

K-Number: K993621 · 1999-12-29

ApplicantPamitex Industries Sdn Bhd
Decision Date1999-12-29
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HEALTH-PLUS, SANITEX, RELIANCE, BLUE PRE-POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (100 MIC is the device name listed in this FDA 510(k) record. The listed applicant is Pamitex Industries Sdn Bhd. It received FDA 510(k) clearance on 1999-12-29 under 510(k) number K993621. 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 HEALTH-PLUS, SANITEX, RELIANCE, BLUE PRE-POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (100 MIC?

HEALTH-PLUS, SANITEX, RELIANCE, BLUE PRE-POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (100 MIC is a medical device that received FDA 510(k) clearance on 1999-12-29. The listed applicant is Pamitex Industries Sdn Bhd. The 510(k) number is K993621.

When did HEALTH-PLUS, SANITEX, RELIANCE, BLUE PRE-POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (100 MIC receive FDA 510(k) clearance?

HEALTH-PLUS, SANITEX, RELIANCE, BLUE PRE-POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (100 MIC received FDA 510(k) clearance on 1999-12-29, under 510(k) number K993621.

Who is the listed applicant for HEALTH-PLUS, SANITEX, RELIANCE, BLUE PRE-POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (100 MIC?

The FDA 510(k) record lists Pamitex Industries Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEALTH-PLUS, SANITEX, RELIANCE, BLUE PRE-POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (100 MIC?

The FDA product code for HEALTH-PLUS, SANITEX, RELIANCE, BLUE PRE-POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (100 MIC is LYY.

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Other records listing Pamitex Industries 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.

K003350HEALTH-PLUS, SANITEX, RELIANCE MULTIPLY POWDER FREE POLYMER AND NITRILE COATED (BLUE)K000952HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATION GLOVES - BLUE COLORK001674POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLORK001672POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVESK993756HEALTH-PLUS, SANITEX, RELIANCE STERILE POWDER-FREE NITRILE SURGICAL GLOVESK000828HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LAXTEX EXAMINATION GLOVE

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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