Ssn Gloves (M) Sdn Bhd
MalaysiaFDA applicant, unverified
- Devices
- 4
What Ssn Gloves (M) Sdn Bhd makes
The company manufactures single-use latex gloves for medical and examination purposes, including powdered and powder-free variants. Products include examination gloves and sterile surgical gloves, with some labeled for reduced protein content. The portfolio also covers latex gloves with protein labeling claims, intended for use in healthcare settings.
These devices are classified as Class I under FDA regulations and are listed via the 510(k) pathway. The manufacturer is based in the US, and the records reflect their FDA submissions for these specific glove products.
Catalogue
Kleenhands Powdered Latex Examination Gloves Ref K990527
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Sterile Powdered Latex Surgical Gloves With Protein Labeling Claim (200 Micrograms Or Less) Ref K012896
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ssn Gloves (M) Sdn Bhd have in the registry?
The registry currently lists 4 devices for Ssn Gloves (M) Sdn Bhd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ssn Gloves (M) Sdn Bhd's devices?
Among its 4 most recently registered devices, Ssn Gloves (M) Sdn Bhd has devices listed in FDA 510(k) (4 devices).
What risk classes do Ssn Gloves (M) Sdn Bhd's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Ssn Gloves (M) Sdn Bhd's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Ssn Gloves (M) Sdn Bhd in the registry?
The most recently registered devices listed for Ssn Gloves (M) Sdn Bhd include KLEENHANDS POWDERED LATEX EXAMINATION GLOVES, STERILE POWDER-FREE LATEX SURGICAL GLOVES (50 MICROGRAMS OR LESS), STERILE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN LABELING CLAIM (200 MICROGRAMS OR LESS) and KLEENHANDS POWDERFREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM.