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FDA 510(k)

DEFEND LATEX EXAM. GLOVES(AMBIDEXT/NON-STER/HYPOAL

K-Number: K903439 · 1991-01-14

ApplicantGlovco Malaysia Sdn Bhd
Decision Date1991-01-14
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DEFEND LATEX EXAM. GLOVES(AMBIDEXT/NON-STER/HYPOAL is the device name listed in this FDA 510(k) record. The listed applicant is Glovco Malaysia Sdn Bhd. It received FDA 510(k) clearance on 1991-01-14 under 510(k) number K903439. 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 DEFEND LATEX EXAM. GLOVES(AMBIDEXT/NON-STER/HYPOAL?

DEFEND LATEX EXAM. GLOVES(AMBIDEXT/NON-STER/HYPOAL is a medical device that received FDA 510(k) clearance on 1991-01-14. The listed applicant is Glovco Malaysia Sdn Bhd. The 510(k) number is K903439.

When did DEFEND LATEX EXAM. GLOVES(AMBIDEXT/NON-STER/HYPOAL receive FDA 510(k) clearance?

DEFEND LATEX EXAM. GLOVES(AMBIDEXT/NON-STER/HYPOAL received FDA 510(k) clearance on 1991-01-14, under 510(k) number K903439.

Who is the listed applicant for DEFEND LATEX EXAM. GLOVES(AMBIDEXT/NON-STER/HYPOAL?

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

What is the FDA product code for DEFEND LATEX EXAM. GLOVES(AMBIDEXT/NON-STER/HYPOAL?

The FDA product code for DEFEND LATEX EXAM. GLOVES(AMBIDEXT/NON-STER/HYPOAL 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 Glovco Malaysia 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.

K892009PATIENT EXAMINATION GLOVES (LATEX)K892010PATIENT EXAMINATION GLOVES (LATEX)

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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