Search Results
Found 2 results
510(k) Data Aggregation
(121 days)
Pentavest Holdings Sdn Bhd
Blue Nitrile Examination Gloves Powder Free is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Blue Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color and are powder free.
The provided text describes the acceptance criteria and performance data for the "Penta Glove," a Blue Nitrile Examination Glove. It is a 510(k) submission, meaning it aims to demonstrate substantial equivalence to a legally marketed predicate device rather than undergoing a de novo approval process.
Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance | Remarks |
|---|---|---|---|---|
| ASTM D6319-2019 (Length) | To determine the length of the gloves | Min 230 mm for all sizes | X-Small: 246 mm, Small: 246 mm, Medium: 248 mm, Large: 248 mm, X-Large: 250 mm | Meets criteria |
| ASTM D6319-2019 (Width) | To determine the width of the gloves | X-small: 70±10 mm, Small: 80±10 mm, Medium: 95±10 mm, Large: 110±10 mm, X-Large: 120±10 mm | X-small: 68 mm, Small: 80 mm, Medium: 92 mm, Large: 105 mm, X-Large: 115 mm | Meets criteria (all reported values are within the +/-10mm range of the nominal size criteria) |
| ASTM D6319-2019 (Thickness) | To determine the thickness of the gloves | Palm 0.05 mm min, Finger 0.05 mm min for all sizes | X-Small: 0.12mm (Palm), 0.20mm (Finger); Small: 0.12mm (Palm), 0.20mm (Finger); Medium: 0.12mm (Palm), 0.20mm (Finger); Large: 0.12mm (Palm), 0.20mm (Finger); X-Large: 0.12mm (Palm), 0.20mm (Finger) | Meets criteria |
| ASTM D6319-2019 (Physical Properties - Tensile Strength) | To Determine the physical properties - Tensile strength | Before Ageing: 14 Mpa Min for all sizes; After Ageing: 14 Mpa Min for all sizes | Before Ageing: X-Small 18.45 Mpa, Small 18.54 Mpa, Medium 18.62 Mpa, Large 18.67 Mpa, X-Large 18.72 Mpa; After Ageing: X-Small 17.54 Mpa, Small 17.56 Mpa, Medium 17.68 Mpa, Large 17.75 Mpa, X-Large 17.80 Mpa | Meets criteria (all reported values are above 14 Mpa) |
| ASTM D6319-2019 (Physical Properties - Ultimate Elongation) | To Determine the physical properties - Ultimate Elongation | Before Ageing: 500% Min for all sizes; After Ageing: 400% Min for all sizes | Before Ageing: X-Small 686%, Small 690%, Medium 694%, Large 702%, X-Large 705%; After Ageing: X-Small 659%, Small 665%, Medium 668%, Large 670%, X-Large 674% | Meets criteria (all reported values are above the minimums) |
| ASTM D5151-2019 (Water Tight / Holes) | To determine the holes in the gloves | AQL 1.5 | Gloves Passes AQL 1.5 | Meets criteria |
| ASTM D6124-06 (Reapproved 2017) (Residual Powder) | To determine the residual powder in the gloves | 2 Mg/Glove Max | X-small: 0.21mg/glove, Small: 0.21mg/glove, Medium: 0.22 mg/glove, Large: 0.22 mg/glove, X-Large: 0.22 mg/glove | Meets criteria |
| ISO 10993-10 (Primary Skin Irritation) | To determine the potential of the material to produce dermal irritation in Rabbits | Under the condition of study not an irritant | Under the condition of study not an irritant | Meets criteria |
| ISO 10993-10 (Dermal Sensitization) | To determine the skin sensitization potential of the material in Guinea Pig | Under the conditions of the study not a sensitizer | Under the conditions of the study not a sensitizer | Meets criteria |
| ISO 10993-5:2009 (In vitro Cytotoxicity) | To evaluate the in vitro cytotoxic potential of the test item extracts in L-929 mouse fibroblasts cells | Under the conditions of study non cytotoxic | Under the conditions of the study cytotoxic. | Does Not Meet Criteria (Reported as "cytotoxic" against a "non cytotoxic" acceptance criteria, though in the previous F. Summary of Technological Characteristics, it was listed as "Same" as predicate with predicate also being "cytotoxic"). This discrepancy needs clarification. |
| ISO 10993-11:2017 (Acute Systemic Toxicity) | To determine the acute systemic toxicity potential of the test item extracts in Swiss Albino mice | Under the conditions of study the device extracts do not pose a systemic toxicity concern | Under the conditions of study the device extracts do not pose a systemic toxicity concern | Meets criteria |
| USP 42 (Bacterial Endotoxin) | To determine the Bacterial Endotoxin limit in the glove | NMT 20 EU/pair of gloves |
Ask a specific question about this device
(111 days)
Pentavest Holdings Sdn Bhd
Sterile Latex Surgical Gloves Powder Free is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
The proposed device, Sterile Latex Surgical Gloves Powder Free with protein content labeling claim of 50 µg/ dm² or less per glove of extractable protein is a sterile and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound from contamination. The proposed device is made of natural rubber latex, as per standard ASTM D3577-2019, Standard Specification for Rubber Surgical Gloves. The classification is: Type I - gloves compounded primarily from natural rubber latex. The proposed device is Sterile Latex Surgical Gloves Powder Free, and variants of different sizes. All variants share the same natural color (No color is added). The proposed device is sterilized using Gamma Radiation method to achieve the Sterility Assurance Level (SAL) of 10 and place in a sterility maintained package to ensure a shelf life of 3 years.
The provided text describes the acceptance criteria and study results for "Sterile Latex Surgical Gloves Powder Free." Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Specification as per ASTM D3577-2019) | Reported Device Performance (Average value of subject device) | Complied with Standard? |
|---|---|---|---|
| Dimensions | |||
| Length (all sizes) | Min 265mm | 383mm (Size 6), 385mm (Size 6.5), 388mm (Size 7), 390mm (Size 7.5), 392mm (Size 8), 394mm (Size 8.5), 396mm (Size 9) | Yes |
| Width (Size 6) | 76+/-6mm | 74mm | Yes |
| Width (Size 6.5) | 83+/-6mm | 86mm | Yes |
| Width (Size 7) | 89+/-6mm | 92mm | Yes |
| Width (Size 7.5) | 95+/-6mm | 98mm | Yes |
| Width (Size 8) | 102+/-6mm | 105mm | Yes |
| Width (Size 8.5) | 108+/-6mm | 110mm | Yes |
| Width (Size 9) | 114+/-6mm | 116mm | Yes |
| Finger Thickness (all sizes) | Min 0.10mm | 0.21mm | Yes |
| Palm Thickness (all sizes) | Min 0.10mm | 0.16mm | Yes |
| Cuff Thickness (all sizes) | Min 0.10mm | 0.12mm | Yes |
| Tensile Strength | |||
| Before aging (all sizes) | 24Mpa minimum | 28.55Mpa | Yes |
| After aging @ 70°±2C for 166±2 hr (all sizes) | 18Mpa minimum | 23.48Mpa | Yes |
| Ultimate Elongation | |||
| Before aging (all sizes) | 750% minimum | 870% | Yes |
| After aging @ 70°±2C for 166±2 hr (all sizes) | 560% minimum | 731% | Yes |
| Stress at 500% | |||
| Before aging (all sizes) | 5.5 MPa Max | 5.1 Mpa | Yes |
| Pinhole AQL | |||
| Before aging (all sizes) | Max 1.5 | 1.0 | Yes |
| After aging @ 70°C for 7 days (all sizes) | Max 1.5 | 1.0 | Yes |
| Powder Residue |
Ask a specific question about this device
Page 1 of 1