Guthrie Medicare Products (Melaka) Sdn Bhd

Country not established

Devices: 12

What Guthrie Medicare Products (Melaka) Sdn Bhd makes

Guthrie Medicare Products (Melaka) Sdn Bhd manufactures a range of single-use latex and nitrile gloves for medical and patient examination purposes, including both powdered and powder-free variants. Their portfolio includes latex surgical gloves, chlorinated latex examination gloves, and nitrile examination gloves, some of which carry protein content labeling claims. These products are designed for clinical and healthcare settings to provide barrier protection during procedures.

The company’s devices are classified under Class I in the FDA regulatory framework and are listed via 510(k) clearance. Their products are intended for use in the US market, adhering to FDA compliance requirements for medical gloves. The manufacturer is based in the US.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue12

Newest first, rows 1-12 of 12

Search and filter all 12 devices

Patient Examination Latex Gloves (Non-Sterile) Ref K911694

Active Regimes: 510(k) Registry: 510(k) Class:I
Guthrie Prime Powder-Free Ref K990228

Active Regimes: 510(k) Registry: 510(k) Class:I
Guthrie Prime Pre-Powdered Patient Latex Examination Glove Ref K993793

Active Regimes: 510(k) Registry: 510(k) Class:I
Nitrile Examination Gloves (Powered) Ref K003922

Active Regimes: 510(k) Registry: 510(k) Class:I
Guthrie Shield Plus Blue Latex Examination Gloves (Powder-Free) Ref K010078

Active Regimes: 510(k) Registry: 510(k) Class:I
Guthrie Latex Surgical Glove (Pre-Powdered) Ref K001047

Active Regimes: 510(k) Registry: 510(k) Class:I
Guthrie Powderfree Latex Examination Gloves Ref K954967

Active Regimes: 510(k) Registry: 510(k) Class:I
Guthrie Prime Powder-Free Chlorinated Patient Examination Gloves Ref K000090

Active Regimes: 510(k) Registry: 510(k) Class:I
Powderfree Nitrile Patient Exmination Glove Ref K003985

Active Regimes: 510(k) Registry: 510(k) Class:I
Guthrie Prime Powdered Latex Examination Gloves With Protein Content Labeling Claim (200 Micrograms Or Less) Ref K003872

Active Regimes: 510(k) Registry: 510(k) Class:I
Guthrie Shield Blue Latex Examination Gloves, Powdered With Protein Content Labeling Claim (200 Micrograms Or Less) Ref K010054

Active Regimes: 510(k) Registry: 510(k) Class:I
Guthrie Powder-Free Latex Surgical Glove With (50 Micrograms Or Less) Ref K001049

Active Regimes: 510(k) Registry: 510(k) Class:I

Rows 1-12 of 12

Frequently asked questions

How many devices does Guthrie Medicare Products (Melaka) Sdn Bhd have in the registry?

The registry currently lists 12 devices for Guthrie Medicare Products (Melaka) Sdn Bhd. Devices recorded under merged duplicate company entries are counted once.

Which registries list Guthrie Medicare Products (Melaka) Sdn Bhd's devices?

Among its 12 most recently registered devices, Guthrie Medicare Products (Melaka) Sdn Bhd has devices listed in FDA 510(k) (12 devices).

What risk classes do Guthrie Medicare Products (Melaka) Sdn Bhd's devices fall under?

Among its 12 most recently registered devices, the classes recorded for Guthrie Medicare Products (Melaka) Sdn Bhd's devices are Class I. Each device page shows its own class and authorisation.

What are the newest devices from Guthrie Medicare Products (Melaka) Sdn Bhd in the registry?

The most recently registered devices listed for Guthrie Medicare Products (Melaka) Sdn Bhd include PATIENT EXAMINATION LATEX GLOVES (NON-STERILE), GUTHRIE PRIME POWDER-FREE, GUTHRIE PRIME PRE-POWDERED PATIENT LATEX EXAMINATION GLOVE and NITRILE EXAMINATION GLOVES (POWERED).

Generated automatically from registry data and not verified by a human reviewer.

What Guthrie Medicare Products (Melaka) Sdn Bhd makes

Catalogue12

Patient Examination Latex Gloves (Non-Sterile) Ref K911694

Guthrie Prime Powder-Free Ref K990228

Guthrie Prime Pre-Powdered Patient Latex Examination Glove Ref K993793

Nitrile Examination Gloves (Powered) Ref K003922

Guthrie Shield Plus Blue Latex Examination Gloves (Powder-Free) Ref K010078

Guthrie Latex Surgical Glove (Pre-Powdered) Ref K001047

Guthrie Powderfree Latex Examination Gloves Ref K954967

Guthrie Prime Powder-Free Chlorinated Patient Examination Gloves Ref K000090

Powderfree Nitrile Patient Exmination Glove Ref K003985

Guthrie Prime Powdered Latex Examination Gloves With Protein Content Labeling Claim (200 Micrograms Or Less) Ref K003872

Guthrie Shield Blue Latex Examination Gloves, Powdered With Protein Content Labeling Claim (200 Micrograms Or Less) Ref K010054

Guthrie Powder-Free Latex Surgical Glove With (50 Micrograms Or Less) Ref K001049

Frequently asked questions