(33 days)
This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Class I latex patient examination gloves 80LYY, powder free and meeting all the requirements of ASTM-D3578-95 Standard Specification for Latex Examination Gloves for Medical Application.
This document describes the acceptance criteria and supporting studies for the ROYAL SHIELD POWDER FREE LATEX EXAMINATION GLOVES WITH BUBBLE GUM SCENT AND PROTEIN CONTENT LABELING.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (from ASTM-D3578-95 unless otherwise specified) | Reported Device Performance (ROYAL SHIELD) |
|---|---|---|
| Dimension | ||
| Width (X-Small) | 70 mm +/- 10 mm | 70 - 75 mm |
| Width (Small) | 80 mm +/- 10 mm | 80 - 85 mm |
| Width (Medium) | 95 mm +/- 10 mm | 90 - 97 mm |
| Width (Large) | 111 mm +/- 10 mm | 105 - 111 mm |
| Length (all sizes) | 230 mm minimum | 242 mm |
| Thickness (Finger) | 0.08 mm min | 0.08 mm min |
| Thickness (Palm) | 0.08 mm min | 0.08 mm min |
| Tensile Strength (Before Aging) | 14.0 Mpa min | 21.0 Mpa |
| Tensile Strength (After Aging - 22 hrs @ 100C) | 14.0 Mpa min | 16.0 Mpa |
| Ultimate Elongation (Before Aging) | 700 % | 800 % |
| Ultimate Elongation (After Aging - 22 hrs @ 100C) | 500 % | 750 % |
| Water Tight Test (AQL) | 4.0% AQL (based on FDA/ASTM requirements) | For 200 samples per size: |
- X-Small: 2 leaked (1%)
- Small: 2 leaked (1%)
- Medium: 1 leaked (0.5%)
- Large: 4 leaked (2%)
(All percentages are within 4.0% AQL) |
| Biocompatibility - Primary Dermal Irritation Test | Must not be a primary irritant | Not a primary irritant |
| Biocompatibility - Skin Sensitization Study | Must not be a sensitizer | Not a sensitiser |
| Residual Powder Content (per ASTM D 6124-97) | 2 mg/glove max (FDA internal requirement) | Range: 1.5 - 1.9 mg/glove (Mean: 1.7 mg/glove) |
| Presence of Cornstarch | Negative | Negative |
| Residual Protein Level (per ASTM D 5712-95) |
§ 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.