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510(k) Data Aggregation
(157 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
Powder Free Blue Nitrile Examination Glove meets all the current specifications listed under the ASTM Specification D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.
The document provided describes the acceptance criteria and performance data for a Powder Free Nitrile Examination Glove (Blue), K220284, in comparison to a predicate device. This is a medical device submission, and the studies described are non-clinical performance data to demonstrate substantial equivalence, not studies related to AI or diagnostic algorithms. Therefore, many of the requested fields related to AI/algorithm performance (e.g., MRMC studies, standalone performance, training set details) are not applicable.
Here's the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|---|
| ASTM D6319-19: Dimensions | To measure the physical length and width of the gloves | Length: XS-Min 220mm, S-Min 220mm, M-Min 230mm, L-Min 230mm, XL-Min 230mm | Minimal Value for Length: XS: 240mm, S: 246mm, M: 240mm, L: 250mm, XL: 251mm | PASS |
| Width: XS-70 ± 10mm, S-80 ± 10mm, M-95 ± 10mm, L-110 ± 10mm, XL-120 ± 10mm | Minimal Value for Width: XS: 73mm, S: 84mm, M: 93mm, L: 104mm, XL: 111mm | PASS | ||
| ASTM D6319-19: Physical Properties | To measure the tensile strength and elongation before and after aging | Tensile Strength: Before Aging: 14.0 MPa, After Aging: 14.0 MPa | Tensile Strength: Before Aging: Minimal Value: 19.10 MPa, After Accelerated Aging: Minimal Value: 19.0 MPa | PASS |
| Ultimate Elongation: Before Aging: min. 500%, After Aging: min. 400% | Ultimate Elongation: Before Aging Minimal Value: 520%, After Aging Minimal Value: 480% | PASS | ||
| ASTM D6319-19: Thickness | To measure the physical palm and finger thickness of the gloves | Palm-Min. 0.05mm | Palm Minimal Value: XS: 0.07mm, S: 0.07mm, M: 0.07mm, L: 0.07mm, XL: 0.07mm | PASS |
| Finger-Min. 0.05mm | Finger Minimal Value: XS: 0.11mm, S: 0.11mm, M: 0.11mm, L: 0.11mm, XL: 0.12mm | PASS | ||
| ASTM D6319-19: Freedom from Holes Testing | To detect the presence of holes in glove | Meet AQL 2.5 at G1 | Meet AQL 2.5 at G1 | PASS |
| ISO 10993-10: Primary Skin Irritation | To determine the irritation potential of glove when exposed to skin surface | Not an irritant | Under the condition of study, not an irritant | PASS |
| ISO 10993-10: Dermal Sensitization | To determine the sensitization potential of glove when exposed to skin surface | Not a Sensitizer | Under the condition of study, not a sensitizer | PASS |
| ISO 10993-11: Acute Systemic Toxicity | To evaluate the adverse systemic reaction potential from glove | Not induce systemic toxicity | Did not induce systemic Toxicity | PASS |
| ASTM D6124-06: Residual Powder Analysis | To check the amount of powder residue from glove surface | Residual powder test ( |
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