Associated Ent., Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Associated Ent., Inc. makes
Associated Ent., Inc. manufactures patient examination gloves, including latex and vinyl versions, and leak detection pouches designed for use with examination gloves. These products are intended for medical and clinical settings to ensure sterility and prevent contamination during procedures.
The company’s portfolio is classified under FDA’s Class I medical devices and is listed via the 510(k) pathway. These products are registered in the U.S. under the FDA’s regulatory framework.
Catalogue
Bud Brand Patient Examination Gloves (Latex) Ref K891836
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Bud Brand Patient Examination Gloves (Vinyl) Ref K891835
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Associated Ent., Inc. have in the registry?
The registry currently lists 4 devices for Associated Ent., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Associated Ent., Inc.'s devices?
Among its 4 most recently registered devices, Associated Ent., Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Associated Ent., Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Associated Ent., Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Associated Ent., Inc. in the registry?
The most recently registered devices listed for Associated Ent., Inc. include BUD BRAND PATIENT EXAMINATION GLOVES (LATEX), DISP MONIT POUCH /GLOVE CK PAT EXAM GLOVE LEAK DET, GLOVE CHECK PATIENT EXAMINATION GLOVE LEAK DETECT. and BUD BRAND PATIENT EXAMINATION GLOVES (VINYL).