(55 days)
A medical glove to be worn on the hand of the health care and similar personnel to prevent contamination between health care personnel and patient.
Class I latex patient examination gloves 80L Y Y, powdered and meeting all the requirements of ASTM-D3578-99 Standard Specification for Latex Examination Gloves for Medical Application.
This document describes the acceptance criteria and performance data for ROYAL SHIELD PINK COLORED POWDERED LATEX EXAMINATION GLOVES WITH AND WITHOUT STRAWBERRY SCENTING & A PROTEIN LABELLING CLAIM.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria (Standard/Claim) | Reported Device Performance |
|---|---|---|
| Dimensions | ||
| Width (Ambidextrous) | X-Small: 70 mm +/- 10 mm | |
| Small: 80 mm +/- 10mm | ||
| Medium: 95 mm +/- 10mm | ||
| Large: 111mm +/- 10mm | Not explicitly reported as meeting all ranges, but device description states meeting ASTM-D3578-99. Implied compliance. | |
| Width (Size Fitted) | 5.5: 70 +/- 10 mm | |
| 6.0: 76 +/- 10mm | ||
| 6.5: 83 +/- 10mm | ||
| 7.0: 89 +/- 10mm | ||
| 7.5: 95 +/- 10mm | ||
| 8.0: 102 +/- 10mm | ||
| 8.5: 108 +/- 10 mm | ||
| 9.0: 114 +/- 10mm | Not explicitly reported as meeting all ranges, but device description states meeting ASTM-D3578-99. Implied compliance. | |
| Length | 230 mm | 230 mm (Min) |
| Thickness - Finger | 0.08 mm min | 0.08 mm min |
| Thickness - Palm | 0.08 mm min | 0.08 mm min |
| Tensile Strength (Aged) | ASTM: 14.0 | Range: 24.7 - 27.4 |
| Tensile Strength (Unaged) | ASTM: 14.0 | Range: 26.4 - 30.3 |
| Ultimate Elongation (Aged) | ASTM: 500 | Range: 900 - 980 |
| Ultimate Elongation (Unaged) | ASTM: 700 | Range: 880 - 900 |
| Water Tight Test (AQL) | ASTM D-3578-99 requirement for latex exam gloves of 2.5% AQL | Batch 9009-9037 XS: 5 leaked (sample size 200) |
| Batch 9019-9023 S: 3 leaked (sample size 315) | ||
| Batch 9030-9039 M: 3 leaked (sample size 200) | ||
| (All figures within 2.5% AQL) | ||
| Biocompatibility - Primary Dermal Irritation | Meet FDA biocompatibility requirements (Not a primary irritant) | Not a primary irritant |
| Biocompatibility - Skin Sensitization | Meet FDA biocompatibility requirements (Not a sensitiser) | Not a sensitiser |
| Residual Protein Level (ASTM D 5712-95) | Claimed Level: |
§ 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.