Perusahaan Intan Emas Sdn. Bhd.
MalaysiaFDA applicant, unverified
- Devices
- 4
What Perusahaan Intan Emas Sdn. Bhd. makes
The company manufactures single-use patient examination gloves, including latex-free options and hypoallergenic variants. Their portfolio includes powder-free and powdered gloves, with some products labeled for low protein content (200 micrograms or less). These gloves are designed for medical and clinical examinations to reduce allergenic risks and improve comfort for both patients and healthcare providers.
The products fall under Class I medical devices and are listed in the FDA’s 510(k) registry. The company is based in the US, and its devices are authorised under US regulatory requirements.
Catalogue
Patient Examination Gloves (Latex) Ref K892074
Regimes: 510(k) Registry: 510(k)Multi-Comfort Powder Free Ref K935033
Regimes: 510(k) Registry: 510(k)Multi-Comfort Powdered Examination Gloves With Protein Content Labeling Claim (200 Micrograms Or Less) Ref K982691
Regimes: 510(k) Registry: 510(k)Hypoallergenic Multi-Comfort Examination Gloves Ref K925363
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Perusahaan Intan Emas Sdn. Bhd. have in the registry?
The registry currently lists 4 devices for Perusahaan Intan Emas Sdn. Bhd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Perusahaan Intan Emas Sdn. Bhd.'s devices?
Among its 4 most recently registered devices, Perusahaan Intan Emas Sdn. Bhd. has devices listed in FDA 510(k) (4 devices).
What risk classes do Perusahaan Intan Emas Sdn. Bhd.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Perusahaan Intan Emas Sdn. Bhd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Perusahaan Intan Emas Sdn. Bhd. in the registry?
The most recently registered devices listed for Perusahaan Intan Emas Sdn. Bhd. include PATIENT EXAMINATION GLOVES (LATEX), MULTI-COMFORT POWDER FREE, MULTI-COMFORT POWDERED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) and HYPOALLERGENIC MULTI-COMFORT EXAMINATION GLOVES.