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FDA 510(k)

POLYKOTE

K-Number: K953299 · 1995-08-07

ApplicantIntl. Trade Management Co.
Decision Date1995-08-07
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POLYKOTE is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Trade Management Co.. It received FDA 510(k) clearance on 1995-08-07 under 510(k) number K953299. 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 POLYKOTE?

POLYKOTE is a medical device that received FDA 510(k) clearance on 1995-08-07. The listed applicant is Intl. Trade Management Co.. The 510(k) number is K953299.

When did POLYKOTE receive FDA 510(k) clearance?

POLYKOTE received FDA 510(k) clearance on 1995-08-07, under 510(k) number K953299.

Who is the listed applicant for POLYKOTE?

The FDA 510(k) record lists Intl. Trade Management Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POLYKOTE?

The FDA product code for POLYKOTE 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 Intl. Trade Management Co. 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.

K954462POLYKOTE POWDER FREE STERILE LATEX SURGEONS GLOVESK951513JAIK950468POWDER FREE STERILE LATEX SURGEONS GLOVESK950467POWDER FREE PATIENT EXAMINATION GLOVESK946203JAI POWDERFREE LATEX EXAMINATION GLOVES

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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