(129 days)
A patient examination glove is a disposable device made of Nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powder Free Nitrile Examination Glove - Black, Non-Sterile meet all requirements of ASTM standard D6319 and FDA 21 CFR 880.6250. The powder free nitrile examination glove is manufactured from Nitrile rubber. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the qloves without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand and it is a single use device.
The document describes the non-clinical testing of a "Powder Free Nitrile Examination Glove - Black, Non Sterile" to demonstrate its substantial equivalence to a predicate device (K190942).
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Method | Standard | Purpose of Testing | Acceptance Criteria | Reported Device Performance | Status |
|---|---|---|---|---|---|
| Physical Properties | ASTM D412 (Standard Test Method for Vulcanized Rubber and Thermoplastic Elastomers-Tension) | To evaluate the tensile (tension) properties of glove. | Before aging: Tensile strength Min 14.0 MPa; Ultimate elongation Min 500% | Before aging: Tensile strength 29.7 Mpa; Ultimate elongation 585% | Pass |
| After aging: Tensile strength Min 14.0 MPa; Ultimate elongation Min 400% | After aging: Tensile strength 33.1 Mpa; Ultimate elongation 554% | Pass | |||
| Dimension | ASTM D3767 (Standard Practice for Rubber—Measurement of Dimensions) | To measure the length, width and thickness of glove. | X-Small: Length Min 240 mm, Width 70 ± 10 mm, Thickness Finger - min 0.05mm, Palm - min 0.05mm | Length 250 mm, Width 78.0 mm, Thickness Finger - 0.10 mm, Palm - 0.07 mm | Pass |
| Small: Length Min 240 mm, Width 80 ± 10 mm, Thickness Finger - min 0.05mm, Palm - min 0.05mm | Length 250 mm, Width 88.0 mm, Thickness Finger - 0.10 mm, Palm - 0.07 mm | Pass | |||
| Medium: Length Min 240 mm, Width 95 ± 10 mm, Thickness Finger - min 0.05mm, Palm - min 0.05mm | Length 250 mm, Width 98.0 mm, Thickness Finger - 0.10 mm, Palm - 0.07 mm | Pass | |||
| Large: Length Min 240 mm, Width 110 ± 10 mm, Thickness Finger – min 0.05mm, Palm - min 0.05mm | Length 249 mm, Width 108 mm, Thickness Finger – 0.10 mm, Palm - 0.07 mm | Pass | |||
| X-Large: Length Min 240 mm, Width 120 ± 10 mm, Thickness Finger – min 0.05mm, Palm - min 0.05mm | Length 250 mm, Width 118 mm, Thickness Finger – 0.10 mm, Palm - 0.07 mm | Pass | |||
| Watertight | ASTM D5151 (Standard Test Method for Detection of Holes in Medical Gloves) | To detect holes that leak water and thereby compromise the usefulness of the glove. | Sample size: 500 pcs, Inspection level: G1, AQL: 1.5, Acceptance No. 10 | Batch size: 150,001 to 500,000. Sample drawn (code M): 315 pieces. 0 pieces found with leaks. Within acceptance criteria. | Pass |
| Residual Powder | ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves) | To determine the amount of residual powder and non-powder solids found on gloves. | Less than 2 mg per glove | Sample size: 5 pcs. Requirement: |
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.