Tritech Mfg. Industries, Inc.
PH Last updated 22 Oct 2026
- Devices
- 1
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
Patient Examination Gloves (Latex) Ref K892606
What Tritech Mfg. Industries, Inc. makes
Tritech Mfg. Industries, Inc. manufactures latex patient examination gloves designed for clinical use, ensuring barrier protection during medical procedures.
These gloves are classified as Class I devices under FDA regulations and are supported by 510(k) clearance records. The company is based in the United States.
Frequently asked questions
What types of medical devices does Tritech Mfg. Industries, Inc. manufacture?
Tritech Mfg. Industries, Inc. specializes in manufacturing patient examination gloves made from latex. These gloves are intended for clinical use to provide a barrier during medical examinations and procedures, helping prevent contamination and infection.
Where is Tritech Mfg. Industries, Inc. based?
The company is headquartered in the United States. This location aligns with regulatory standards and manufacturing practices relevant to its medical device offerings.
How are Tritech’s medical devices classified under FDA regulations?
Tritech’s latex patient examination gloves fall under Class I classification by the FDA. This classification is typically assigned to low-risk devices where general controls are sufficient to ensure safety and effectiveness, and it often involves 510(k) clearance for market authorization.
Which regulatory registries or databases list Tritech’s devices?
Tritech’s devices are documented in the FDA’s 510(k) clearance database, which records pre-market submissions for Class I devices requiring clearance. This registry helps verify compliance and authorization status for its latex examination gloves.
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