Perusahaan Pelindung Getah (M) Sdn Bhd
Country not established
- Devices
- 8
What Perusahaan Pelindung Getah (M) Sdn Bhd makes
The company manufactures powdered and powder-free latex examination gloves for patient use, including low-modulus and polymer-coated variants. Products are marketed with protein labeling claims, specifying low residual protein content (≤50 or ≤100 micrograms). Some variants are chlorinated or contain additives like polymer coatings to enhance durability or reduce powder residue.
All listed devices fall under Class I regulatory classification and are submitted via FDA 510(k) clearance. The manufacturer is based in the US and registers its products through the FDA’s regulatory pathways.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Powder Free Natural Rubber Low Modulus Latex Patient Examination Gloves With A Protein Labeling Claim Ref K072300
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Rubbercare Powdered Latex Examination Gloves Ref K032201
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Rubbercare Patient Examination Glove Ref K891123
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Perusahaan Pelindung Getah (M) Sdn Bhd have in the registry?
The registry currently lists 8 devices for Perusahaan Pelindung Getah (M) Sdn Bhd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Perusahaan Pelindung Getah (M) Sdn Bhd's devices?
Among its 8 most recently registered devices, Perusahaan Pelindung Getah (M) Sdn Bhd has devices listed in FDA 510(k) (8 devices).
What risk classes do Perusahaan Pelindung Getah (M) Sdn Bhd's devices fall under?
Among its 8 most recently registered devices, the classes recorded for Perusahaan Pelindung Getah (M) Sdn Bhd's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Perusahaan Pelindung Getah (M) Sdn Bhd in the registry?
The most recently registered devices listed for Perusahaan Pelindung Getah (M) Sdn Bhd include RUBBERCARE POWDER-FREE, GUARDIAN POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS), POWDER FREE NATURAL RUBBER LOW MODULUS LATEX PATIENT EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM, RUBBERCARE POLYMER-COATED POWDERED LATEX EXAMINATION GLOVES/GUARDIAN POLYMER-COATED POWDERED EXAMINATION GLOVES. CONTAI and RUBBERCARE POWDERED LATEX EXAMINATION GLOVES.