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FDA 510(k)

PATIENT EXAM GLOVES (MFG. TERANG NUSA)

K-Number: K891817 · 1989-08-18

ApplicantMulpha Intl. Trading Corp. Bhd.
Decision Date1989-08-18
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PATIENT EXAM GLOVES (MFG. TERANG NUSA) is the device name listed in this FDA 510(k) record. The listed applicant is Mulpha Intl. Trading Corp. Bhd.. It received FDA 510(k) clearance on 1989-08-18 under 510(k) number K891817. 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 PATIENT EXAM GLOVES (MFG. TERANG NUSA)?

PATIENT EXAM GLOVES (MFG. TERANG NUSA) is a medical device that received FDA 510(k) clearance on 1989-08-18. The listed applicant is Mulpha Intl. Trading Corp. Bhd.. The 510(k) number is K891817.

When did PATIENT EXAM GLOVES (MFG. TERANG NUSA) receive FDA 510(k) clearance?

PATIENT EXAM GLOVES (MFG. TERANG NUSA) received FDA 510(k) clearance on 1989-08-18, under 510(k) number K891817.

Who is the listed applicant for PATIENT EXAM GLOVES (MFG. TERANG NUSA)?

The FDA 510(k) record lists Mulpha Intl. Trading Corp. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PATIENT EXAM GLOVES (MFG. TERANG NUSA)?

The FDA product code for PATIENT EXAM GLOVES (MFG. TERANG NUSA) 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 Mulpha Intl. Trading Corp. 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.

K891812PATIENT EXAM GLOVES (MFG. GETAH GAYAL)K891811PATIENT EXAM GLOVES (MFG. PALMBASE RUBBER MFG.)K891816PATIENT EXAM GLOVES (MFG. HEALTHCARE GLOVES)K891813PATIENT EXAM GLOVES (MFG. AEK RUBBER PRODUCTS)K891815PATIENT EXAM GLOVES (MFG. M.R. RUBBER INDUSTRIES)

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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