TG Medical Powder-Free Latex Examination Glove (Protein Labeling Claim, 50 Micrograms or Less)
510(k) K982872
Active
Valid until
Not listed
FDA recalls
None ongoingTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK982872 | Date15 Oct 1998 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
-
- Terminated Z-0909-06
FDA's laboratory analysis found holes in the gloves that exceeded the allowable limit. Gloves with holes compromise the integrity of the latex barrier and have the potential to allow hazardous substances to come into contact with the user's skin.
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- Withdrawn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, 1 Oct 2026
This device is a powder-free latex examination glove classified under the General Hospital category, designed for single-use in medical, dental, and laboratory settings. It complies with the EN 455 standard for medical gloves, providing a barrier against pathogens and chemical exposure. The glove features a polymer coating and meets a protein labeling claim of 50 micrograms or less, reducing the risk of allergic reactions. Its construction ensures tactile sensitivity while maintaining durability for clinical procedures.
Supplied as a single-use item, these gloves are intended for sterile use in controlled environments such as hospitals, clinics, and laboratories. They are packaged individually and must be stored in a clean, dry place away from direct sunlight or extreme temperatures. The device holds FDA 510(k) clearance (K982872) and MDR authorization, confirming compliance with regulatory standards for medical gloves. Sizes are not specified in the data, but adherence to EN 455 ensures consistency in performance and safety.
Other devices from Tg Medical Sdn. Bhd.
Questions
AI-generated answers, 1 Oct 2026
What is the TG Medical powder-free latex examination glove designed for?
This glove is designed for single-use in medical, dental, and laboratory settings. Its construction provides a barrier against pathogens and chemical exposure, making it suitable for clinical procedures where sterility and tactile sensitivity are required. The polymer coating enhances durability while maintaining precision.
How is this glove supplied and intended for use?
The gloves are supplied individually as single-use items, intended for sterile use in controlled environments like hospitals, clinics, and labs. Each glove is packaged separately to maintain sterility until use. They must be handled in a way that preserves their sterile condition.
What does the protein labeling claim of 50 micrograms or less mean?
The protein labeling claim of 50 micrograms or less indicates a reduced risk of allergic reactions for latex-sensitive individuals. Lower protein content correlates with fewer allergens, making these gloves safer for users with latex sensitivities while still meeting performance standards.
Are these gloves reusable or single-use?
These gloves are explicitly designed for single-use only. Reusing them compromises sterility and barrier integrity, increasing the risk of contamination and infection. They must be discarded after one use to comply with medical safety protocols.
How should these gloves be stored?
Storage requires a clean, dry environment away from direct sunlight or extreme temperatures. Moisture, heat, or light can degrade the glove material, compromising sterility and performance. Always check packaging for expiration dates before use.