(79 days)
This non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The subject device in this 510(k) Notification is Iconic Latex Glove - Powder Free Latex Examination Glove. The subject device is a patient examination glove made from Latex compound, Natural White color, powder free and non-sterile (Per 21 CFR 880.6250 - class I). The device meets the specifications in ASTM D3578-19 Standard specification for Rubber Examination Gloves. The available sizes of the subject devices are Small, Medium, Large, X-Larqe.
The information provided describes the acceptance criteria and the study conducted for the Iconic Latex Glove, a non-powdered patient examination glove.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Characteristics / Test Methodology | Acceptance Criteria (from Section 4.0 and 7.0) | Reported Device Performance (Average Results from Section 8.0) | Final Results (from Section 8.0) |
|---|---|---|---|
| Product Code | LYY | LYY | same |
| Intended Use | A powder-free patient examination glove, disposable, for medical purposes, worn on examiner's hand to prevent contamination between patient and examiner. For over-the-counter use. | This powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The device is for over-the-counter use. | same |
| Material Used | Latex - Natural Rubber | Latex - Natural Rubber | same |
| Color | N/A (Predicate: Natural White) | Natural White | same |
| Sterility | Sterile/Non-sterile | Non sterile | - (Not explicitly "same", but matches expectation) |
| Single Use | Single use | Single use | same |
| Freedom from pinholes (ASTM D5151-19) | AQL 2.5 Inspection Level G-1 | Pass (across all sizes) | Pass |
| Overall Length (ASTM D3578-19) | Min 230mm | Small: 230.8mm, Medium: 240.5mm, Large: 237.5mm, X-Large: 236.8mm | Pass |
| Width (ASTM D3578-19) | Small - 80mm (±10mm); Medium - 95mm (±10mm); Large - 110mm (±10mm); X-Large - 120mm (±10mm) (Note: Table in 4.0 has typo for Large - 110 vs table in 7.0/8.0 as 111) | Small: 83mm, Medium: 96mm, Large: 108.4mm, X-Large: 118.7mm | Pass |
| Thickness at Palm (ASTM D3578-19) | Min 0.05 mm (from Section 4.0) Min: 0.08 mm (from Section 7.0/8.0) | 0.14mm (Small), 0.13mm (Medium), 0.12mm (Large), 0.14mm (X-Large) | Pass |
| Thickness at Fingertip (ASTM D3578-19) | Min 0.05 mm (from Section 4.0) Min: 0.08 mm (from Section 7.0/8.0) | 0.10mm (Small), 0.10mm (Medium), 0.09mm (Large), 0.14mm (X-Large) | Pass |
| Physical Properties Before Aging (ASTM D3578-19) | Tensile Strength = 18 MPa, min.; Ultimate Elongation = 650 % min | Tensile Strength: 20.8 (S), 23.4 (M), 21.4 (L), 20.7 (XL); Ultimate Elongation: 1018.7 (S), 878.9 (M), 1127.9 (L), 1097.6 (XL) | Pass |
| Stress at 500% Elongation (Before Aging) | N/A (Standard specifies min tensile and ultimate elongation) | 3.3 (S), 3.9 (M), 3.7 (L), 3.3 (XL) | Pass |
| Physical Properties After Accelerated Aging (ASTM D3578-19) | Tensile Strength = 14 MPa, min.; Ultimate Elongation = 500 % min | Tensile Strength: 15.3 (S), 17.3 (M), 16.9 (L), 17.4 (XL); Ultimate Elongation: 856.4 (S), 890.8 (M), 1077.3 (L), 956.8 (XL) | Pass |
| Residual Powder (ASTM D6124-06) |
§ 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.