Perusahaan Getah Asas Sdn. Bhd.

Country not established FDA

Devices: 28
Registrations: FDA
FDA recalls: 0

At a glance

Counted by deviCERTS from registry records

Market reach

United States: FDA establishment

What Perusahaan Getah Asas Sdn. Bhd. makes

The company manufactures single-use patient examination gloves in latex, nitrile, and co-polymer materials, including powdered and powder-free variants. Products are available in white, green, and blue colors, with some featuring chlorinated or polymer coatings. Specific claims include low protein content, low modulus, and barrier-protective properties. The portfolio also includes gloves labeled for protein extractable content and those designed for sensitive skin applications.

All listed devices fall under Class I regulatory classification in the US, with authorisation records maintained in the FDA 510(k) database. The manufacturer is based in the United States and adheres to US regulatory requirements for single-use examination gloves.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue28

Newest first, rows 1-28 of 28

Search and filter all 28 devices

Rows 1-28 of 28

FDA establishments1

Registered with the FDA under this company group, matched by name.

Perusahaan Getah Asas Sdn. Bhd. JERAM Selangor · MY FEI 3004553390

Frequently asked questions

How many devices does Perusahaan Getah Asas Sdn. Bhd. have in the registry?

The registry currently lists 28 devices for Perusahaan Getah Asas Sdn. Bhd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Perusahaan Getah Asas Sdn. Bhd.'s devices?

Among its 28 most recently registered devices, Perusahaan Getah Asas Sdn. Bhd. has devices listed in FDA 510(k) (28 devices).

What risk classes do Perusahaan Getah Asas Sdn. Bhd.'s devices fall under?

Among its 28 most recently registered devices, the classes recorded for Perusahaan Getah Asas Sdn. Bhd.'s devices are Class I. Each device page shows its own class and authorisation.

What are the newest devices from Perusahaan Getah Asas Sdn. Bhd. in the registry?

The most recently registered devices listed for Perusahaan Getah Asas Sdn. Bhd. include POWDER-FREE BARRIER-PRO CO-POLYMER EXAMINATION GLOVE, WHITE (NON-COLORED), AND GREEN COLORED, NITRILE PATIENT EXAMINATION GLOVE, PATIENT EXAMINATION GLOVES (LATEX)(POWDERED) and POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), OR BLUE COLORED, WITH EXTRACTABLE PROTEIN CONTENT LABE.

Which FDA establishments are linked to Perusahaan Getah Asas Sdn. Bhd.?

1 FDA establishment is linked to Perusahaan Getah Asas Sdn. Bhd. in the registry; they are listed on the company page.

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

Perusahaan Getah Asas Sdn. Bhd.

At a glance

Market reach

What Perusahaan Getah Asas Sdn. Bhd. makes

Catalogue28

Powder-Free Barrier-Pro Co-Polymer Examination Glove, White (Non-Colored), And Green Colored Ref K031625

Nitrile Patient Examination Glove Ref K982440

Patient Examination Gloves (Latex)(Powdered) Ref K891640

Powder-Free Latex Patient Examination Glove, White (Non-Colored), Or Blue Colored, With Extractable Protein Content Labe Ref K031414

Chlorinated, Polymer Coated, Powder-Free Latex Examination Glove Ref K031021

On-Line Powder-Free Latex Examination Glove, Type Ii, Low Modulus, With Protein Labeling Claim Ref K030331

Polymer Coated, Powder-Free Latex Examination Glove With Protein Labelling Claim, Contains 50 Micrograms Or Less Of Tota Ref K001529

Barrier-Pro Co-Polymer Patient Examination Glove, Powdered, White (Non-Colored) Or Green Colored Ref K031768

Chlorinated, Polymer Coated, Powder-Free Latex Examination Glove Ref K982806

Powder-Free Nitrile Patient Examination Glove Ref K983729

Latex Examination Glove, Powedered Type Ii, Low Modulus, With Protein Labling Claim Ref K030333

Powder Free Latex Examination Gloves Ref K954365

Powder-Free Nitrile Patient Examination Glove, White (Non Colored) Ref K984605

On-Line Powder-Free Nitrile Examination Glove, Violet Colored Ref K030335

Powder-Free Nitrile Patient Examination Glove, Purple Color Ref K010719

Nitrile Patient Examination Glove, Blue Or Green Colored (Prepowdered Usp) Ref K984356

Powdered Nitrile Examination Glove, White (Non-Colored) Ref K991511

Latex Patient Examination Gloves Powdered With Protein Content Labeling Claim; 100 Microgram Or Less Of Total Water Extr Ref K002314

Powder-Free Latex Examination Glove (Surface Treated With Aloe Vera Gel) Ref K022601

Powder-Free Coated Nitrile Examination Glove, Blue Colored Ref K024184

Powder-Free Latex Examination Glove, Blue Colored Ref K011271

Powder-Free, Latex Examination Glove Coated With Aloe Vera Gel And Vitamin E Ref K022701

Powder-Free Latex Examination Glove With Protein Labeling Claim (200 Microgram Per Gram Of Glove Or Less) Ref K023262

Powder-Free Nitrile Patient Examination Glove, White (Non-Colored), Blue And Green Colored Ref K031591

Polymer Coated, Powder-Free Latex Examination Glove Ref K982807

Powder-Free Latex Examination Gloves With Protein Labeling Claim Ref K980916

Powder-Free Nitrile Patient Chemotherapy Examination Glove, Blue Colored Ref K032374

Powdered Latex Patient Examination Glove With Protein Content Labeling Claim (200 Microgramsper Or Less) Ref K003737

FDA establishments1

Frequently asked questions