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FDA 510(k)

GLOVE SEAL D'PRO LATEX EXAMINATION GLOVE

K-Number: K983570 · 1999-01-14

ApplicantGlove Seal Sdn Bhd
Decision Date1999-01-14
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GLOVE SEAL D'PRO LATEX EXAMINATION GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Glove Seal Sdn Bhd. It received FDA 510(k) clearance on 1999-01-14 under 510(k) number K983570. 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 GLOVE SEAL D'PRO LATEX EXAMINATION GLOVE?

GLOVE SEAL D'PRO LATEX EXAMINATION GLOVE is a medical device that received FDA 510(k) clearance on 1999-01-14. The listed applicant is Glove Seal Sdn Bhd. The 510(k) number is K983570.

When did GLOVE SEAL D'PRO LATEX EXAMINATION GLOVE receive FDA 510(k) clearance?

GLOVE SEAL D'PRO LATEX EXAMINATION GLOVE received FDA 510(k) clearance on 1999-01-14, under 510(k) number K983570.

Who is the listed applicant for GLOVE SEAL D'PRO LATEX EXAMINATION GLOVE?

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

What is the FDA product code for GLOVE SEAL D'PRO LATEX EXAMINATION GLOVE?

The FDA product code for GLOVE SEAL D'PRO 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 Glove Seal 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.

K891147PATIENT EXAMINATION GLOVE (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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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