Spi Gloves Sdn. Bhd.
MalaysiaFDA applicant, unverified
- Devices
- 7
What Spi Gloves Sdn. Bhd. makes
Spi Gloves Sdn. Bhd. manufactures single-use examination gloves in various materials, including powder-free nitrile, chlorinated powder-free latex with reduced protein content, powdered latex with protein labeling, and polymer-coated versions of these materials. The gloves are available in multiple colors and include both powdered and powder-free formulations. Some products explicitly claim low protein levels to reduce allergic reactions.
The company’s examination gloves fall under Class I medical devices and are listed in the FDA’s 510(k) registry. These products are intended for use in clinical examinations and medical procedures. The manufacturer is based in Malaysia.
Catalogue
Powder Free Nitrile Examination Gloves (Blue) Ref K050528
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Polymer Coated Powder Free Nitrile Examination Gloves (Blue, White, Violet, Pink, Green) Ref K050530
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Spi Gloves Sdn. Bhd. have in the registry?
The registry currently lists 7 devices for Spi Gloves Sdn. Bhd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Spi Gloves Sdn. Bhd.'s devices?
Among its 7 most recently registered devices, Spi Gloves Sdn. Bhd. has devices listed in FDA 510(k) (7 devices).
What risk classes do Spi Gloves Sdn. Bhd.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Spi Gloves Sdn. Bhd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Spi Gloves Sdn. Bhd. in the registry?
The most recently registered devices listed for Spi Gloves Sdn. Bhd. include POWDER FREE NITRILE EXAMINATION GLOVES (BLUE), CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WA, POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABL and POLYMER COATED ONLINE CHLORINATED POWDER FREE EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR.