Latex Med.exam.gloves Powdered Ambidextrous
510(k) K915126
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK915126 | Date11 Feb 1992 | StatusActive |
| European Union | CE/IVDR EUDAMED | Number— | Date— | StatusActive |
| European Union | CE/IVDD EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- LYY
- Device Class
- Class I
- Regulation
- 21 CFR Part 880.6250
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Latex Medical Examination Gloves, Powdered, Ambidextrous are classified as a powdered latex examination glove under the FDA’s product code LYY. These gloves are designed for single-use in clinical settings to provide a barrier against pathogens and contaminants during medical examinations and procedures, ensuring hygiene and tactile sensitivity for healthcare professionals.
Supplied in sterile packs, these gloves are intended for reusable or single-use applications in general hospital environments. They are authorized under FDA 510(k) clearance (K915126) and comply with the In Vitro Diagnostic Device Directive (IVDD) and In Vitro Diagnostic Regulation (IVDR). The ambidextrous design accommodates both left- and right-handed users, and the powdered formulation facilitates easy donning. Storage requires protection from moisture and extreme temperatures to maintain sterility.
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Questions
AI-generated answers, 18 Sep 2026
Are these gloves intended for reuse, or are they strictly single-use only?
These gloves are supplied sterile and labeled as suitable for single-use, though the manufacturer notes they can also be used in reusable applications within general hospital settings. The powdered formulation and ambidextrous design support ease of use, but the sterility is maintained only for the intended single-use cycle unless reprocessed under controlled conditions.
What storage conditions are required to keep these gloves sterile and functional?
To preserve sterility and integrity, these gloves must be stored protected from moisture and extreme temperatures. Avoid exposure to humidity, direct sunlight, or temperature fluctuations, as these can compromise the latex material and powdered coating. Check the packaging for any additional storage instructions, but the manufacturer emphasizes maintaining a stable environment.
Do these gloves accommodate both left- and right-handed users, and how does that benefit clinicians?
Yes, these gloves are ambidextrous, meaning they are designed to fit comfortably for both left- and right-handed users. This feature enhances usability by reducing the need for clinicians to switch between left- and right-handed gloves, improving efficiency and minimizing the risk of cross-contamination during procedures.
What regulatory pathways have these gloves undergone, and what does that mean for compliance?
These gloves are authorized under FDA 510(k) clearance (K915126), classified under product code LYY for general hospital use, and comply with both the In Vitro Diagnostic Device Directive (IVDD) and In Vitro Diagnostic Regulation (IVDR). The clearance indicates they are deemed substantially equivalent to a predicate device, ensuring they meet FDA safety and performance standards for medical examination gloves.