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non-sterile powder free green latex patient exam gloves with surface coating protein labeling claim 50ug dm2
Sgmp
Summary: These are non-sterile, powder-free latex exam gloves with a low protein content, used primarily by healthcare professionals for patient examinations and procedures to maintain hygiene and prevent contamination.
FDA Clearance Information
Pathway 510K
Number K023537 ↗
Decision Date November 20, 2003
Product Code LYY
Device Class Class 1
Evidence 0 studies
This device was cleared through the FDA 510k pathway on November 20, 2003. Manufactured by Sgmp, it is classified as a Class 1 medical device.
What It Is
These gloves are non-sterile, powder-free, and made of green latex with a surface coating that limits protein content to 50 micrograms per square decimeter. They are designed to provide a barrier between the clinician and the patient, reducing the risk of cross-contamination and exposure to pathogens. The low protein content minimizes the risk of allergic reactions in both patients and healthcare providers.
Clinical Applications
These gloves are commonly used in various clinical settings, including hospitals, clinics, and outpatient facilities, for routine examinations and minor procedures. They are suitable for use in specialties such as general medicine, emergency care, and dermatology. The gloves are designed for single-use applications, ensuring hygiene and safety in patient care.
Indications for Use
These gloves are intended for use in medical examinations and procedures to protect both the patient and the healthcare provider from contamination and infection. They are particularly useful in settings where maintaining a sterile environment is not required.
Practical Considerations
The gloves are available in multiple sizes to ensure a proper fit for different users. They are compatible with most medical equipment and do not interfere with tactile sensitivity. It is important to select the correct size to maintain dexterity and comfort during use.
Frequently Asked Questions
What is non-sterile latex exam gloves used for?
They are used for patient examinations and minor procedures to prevent contamination and ensure hygiene.
What specialties typically use this device?
Specialties such as general medicine, emergency care, and dermatology commonly use these gloves.
What are the FDA-cleared indications?
The gloves are indicated for use in medical examinations and procedures to protect against contamination and infection.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.