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FDA 510(k)

PYNE/CHEMO-TOUCH, ULTRA-SHIELD, PYNE-STERIE, MODIF

K-Number: K914628 · 1991-11-07

ApplicantMedical Resources, Ltd.
Decision Date1991-11-07
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PYNE/CHEMO-TOUCH, ULTRA-SHIELD, PYNE-STERIE, MODIF is the device name listed in this FDA 510(k) record. The listed applicant is Medical Resources, Ltd.. It received FDA 510(k) clearance on 1991-11-07 under 510(k) number K914628. 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 PYNE/CHEMO-TOUCH, ULTRA-SHIELD, PYNE-STERIE, MODIF?

PYNE/CHEMO-TOUCH, ULTRA-SHIELD, PYNE-STERIE, MODIF is a medical device that received FDA 510(k) clearance on 1991-11-07. The listed applicant is Medical Resources, Ltd.. The 510(k) number is K914628.

When did PYNE/CHEMO-TOUCH, ULTRA-SHIELD, PYNE-STERIE, MODIF receive FDA 510(k) clearance?

PYNE/CHEMO-TOUCH, ULTRA-SHIELD, PYNE-STERIE, MODIF received FDA 510(k) clearance on 1991-11-07, under 510(k) number K914628.

Who is the listed applicant for PYNE/CHEMO-TOUCH, ULTRA-SHIELD, PYNE-STERIE, MODIF?

The FDA 510(k) record lists Medical Resources, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PYNE/CHEMO-TOUCH, ULTRA-SHIELD, PYNE-STERIE, MODIF?

The FDA product code for PYNE/CHEMO-TOUCH, ULTRA-SHIELD, PYNE-STERIE, MODIF is LYY.

Related Clinical Trials

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Other records listing Medical Resources, Ltd. 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.

K931250PHYNE-TOUCH PFK903559HIGH RISKK895195CHEMO-TOUCHK894212PHYNE-TOUCH-STERILEK885096PHYNE-VUK890983PHYNE-TOUCH (PATIENT EXAMINATION GLOVES)

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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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