(90 days)
The disposable nitrile medical examination glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
The subject device is powder free nitrile examination gloves. The subject device is available in color blue and white, and it provides five specifications: XS,S, M, L, and XL. The subject device is non-sterile.
The provided text describes the acceptance criteria and the study results for a Disposable Nitrile Examination Glove.
Here's the information extracted and formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ISO 10993-23:2021 Tests For Irritation | To determine if device is a skin irritant | The device must be a non-irritant | Pass |
| ISO 10993-10:2021 Tests For Skin Sensitization | To determine if device is a skin sensitizer | The device must be a non-sensitizer | Pass |
| ISO 10993-5:2009 Tests For In Vitro Cytotoxicity | To determine if the device is potential toxicity to L-929 cells. | The device must be a non toxicity. | Cytotoxic (Note: The summary later states this is the same as the reference device and does not affect substantial equivalence due to acute systemic toxicity results.) |
| ISO 10993-11:2017 Tests for Acute systemic toxicity | To determine if the device will cause acute systemic toxicity in vivo | The device must be a Non-acute systemic toxicity | Pass |
| ASTM D6319 (Physical Dimensions) | Physical Dimensions Test | Length(mm): S:≥220; M/L/XL:≥230; Width(mm): XS: 70±10mm; S:80±10mm; M:95±10mm; L: 110±10mm; XL: 120±10mm; Thickness (mm): Finger: ≥0.05, Palm: ≥0.05 | Length: > 240/Pass (for all sizes) |
| Width (Blue color): XS: 74-76 /Pass; S: 82-86 /Pass; M: 95-97/ Pass; L: 104-106/ Pass; XL:115-117/ Pass | |||
| Width (White Color): XS: 73-76 /Pass; S: 80-87 /Pass; M: 100-103/ Pass; L: 104-106/ Pass; XL:114-117/ Pass | |||
| Thickness (Blue color): XS: Finger:0.10-0.12/Pass, Palm: 0.06-0.10/Pass; S: Finger: 0.09-0.12/Pass, Palm:0.07-0.09/Pass; M: Finger: 0.08 -0.12/Pass, Palm: 0.07-0.09/Pass; L: Finger: 0.09-0.12/Pass, Palm: 0.06-0.09/Pass; XL: Finger: 0.11-0.12/Pass, Palm: 0.06-0.09/Pass | |||
| Thickness (White Color): Details for XS are visible, other sizes indicated but not fully detailed, likely indicating pass. | |||
| ASTM D6319 (Physical Properties) | Tensile Strength | Before Aging: ≥14MPa, After Aging: ≥14MPa | Before Aging: Blue color: 20-30/Pass; White Color: 16-35/Pass |
| After Aging: Blue color: 20-30/Pass; White Color: 16-35/Pass | |||
| ASTM D6319 (Physical Properties) | Ultimate Elongation | Before Aging: ≥500%, After Aging: ≥400% | Before Aging: Blue color: 511-565/Pass; White Color: 436-521/Pass |
| After Aging: Blue color: 511-565/Pass; White Color: 436-521/Pass | |||
| ASTM D6319 / ASTM D5151-19 | Freedom from Holes | G-1, AQL 2.5 | Complies with ASTM D6319-19 and ASTM D5151-19, G-1, AQL 2.5 (Implies Pass) |
| ASTM D6319-19 | Powder Content |
§ 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.