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510(k) Data Aggregation
(197 days)
Sterile Latex Surgical Gloves Powder Free
A 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 and ETO method to achieve the Sterility Assurance Level (SAL) of 10 and place in a sterility maintained package to ensure a shelf life of 5years.
The provided text describes the acceptance criteria and the study that proves the device meets those criteria for Sterile Latex Surgical Gloves Powder Free (K212596), intended to be worn in operating rooms. The study is a non-clinical performance (bench testing) study demonstrating substantial equivalence to a predicate device (K192328).
Here's the breakdown of the information requested, based on the provided document:
Acceptance Criteria and Device Performance Study for Sterile Latex Surgical Gloves Powder Free (K212596)
The study performed is a non-clinical performance (bench testing) study, as explicitly stated under "SUMMARY OF NONCLINICAL PERFORMANCE DATA" and "SUMMARY OF CLINICAL PERFORMANCE DATA: Clinical data was not required for this submission." This type of study focuses on technical and physical characteristics rather than performance in a clinical setting with human participants.
1. Table of Acceptance Criteria and the Reported Device Performance
The acceptance criteria are generally based on ASTM D3577-2019, Standard Specification for Rubber Surgical Gloves, and other specific standards for each test.
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance (Average Value of Subject Device) | Met Acceptance Criteria? |
|---|---|---|---|
| Dimensions | ASTM D3577-2019 | ||
| Length (All sizes) | Min 265 mm | Varies by size (e.g., Size 7: 486 mm, Size 9: 488 mm) | Yes |
| Width (e.g., Size 7) | 89 ± 6 mm | 91 mm | Yes |
| Finger Thickness (All sizes) | Min 0.10 mm | 0.33 mm | Yes |
| Palm Thickness (All sizes) | Min 0.10 mm | 0.21 mm | Yes |
| Cuff Thickness (All sizes) | Min 0.10 mm | 0.16 mm | Yes |
| Tensile Strength | ASTM D3577-2019 | ||
| Before aging (All sizes) | 24 MPa minimum | 28.61 MPa | Yes |
| After aging (All sizes) | 18 MPa minimum | 24.12 MPa | Yes |
| Ultimate Elongation | ASTM D3577-2019 | ||
| Before aging (All sizes) | 750% minimum | 871% | Yes |
| After aging (All sizes) | 560% minimum | 732% | Yes |
| Stress at 500% before aging | 5.5 MPa Max | 5.1 MPa | Yes |
| Pinhole AQL | ASTM D3577-2019, ASTM D5151-2019 | ||
| Before aging (All sizes) | Max 1.5 | 1.0 | Yes |
| After aging (All sizes) | Max 1.5 | 1.0 | Yes |
| Freedom from Holes AQL | AQL 1.0 (ASTM D3577-2019, ASTM D5151-2019) | 1.0 | Yes |
| Powder Residue | `) | Non-pyrogenic | Yes |
| Systemic Toxicity | Device extracts do not pose a systemic toxicity concern (ISO 10993-11) | Device extracts do not pose a systemic toxicity concern | Yes |
| Bacterial Endotoxin | `) |
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(111 days)
Sterile Latex Surgical Gloves Powder Free
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 |
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(127 days)
Sterile Latex Surgical Gloves Powder Free
A 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 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 -09(2015), 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 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 document is a 510(k) Premarket Notification for a medical device: "Sterile Latex Surgical Gloves powder free." This document focuses on demonstrating substantial equivalence to an existing predicate device, rather than proving the device meets clinical acceptance criteria for an AI/ML medical device. Therefore, many of the requested points related to AI/ML study design (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth for training set) are not applicable to this type of submission.
However, the document does contain information about performance testing against established standards, which serve as the acceptance criteria for this specific device.
Here's an analysis of the provided information, addressing the relevant points and noting those that are not applicable:
Device Name: Sterile Latex Surgical Gloves powder free
Submission Type: 510(k) Premarket Notification (for substantial equivalence)
1. A table of acceptance criteria and the reported device performance
The document provides extensive tables comparing the subject device's performance to the predicate device and against the specifications outlined in relevant ASTM standards. These standards define the "acceptance criteria" for the physical and chemical properties of surgical gloves.
Summary Table of Acceptance Criteria and Reported Performance (Selected Key Parameters)
| Criteria Category | Performance Criterion Source (Standard/Section) | Acceptance Criteria | Reported Device Performance (K211478) | Proof of Meeting Criteria |
|---|---|---|---|---|
| Physical Dimensions | ASTM D3577-09 (Reapproved 2015) | Min 265mm (Length, all sizes) | 385mm - 396mm (All sizes) | Met |
| ASTM D3577-09 (Reapproved 2015) | Various +/- 6mm (Width, per size) | 74mm - 116mm (All sizes) | Met | |
| ASTM D3577-09 (Reapproved 2015) | Min 0.10mm (Finger Thickness, all sizes) | 0.20mm | Met | |
| ASTM D3577-09 (Reapproved 2015) | Min 0.10mm (Palm Thickness, all sizes) | 0.15mm | Met | |
| ASTM D3577-09 (Reapproved 2015) | Min 0.10mm (Cuff Thickness, all sizes) | 0.12mm | Met | |
| Physical Properties | ASTM D3577-09 (Reapproved 2015) | 24 Mpa minimum (Tensile Strength, Before Aging) | 27.2 Mpa - 29.7 Mpa | Met |
| ASTM D3577-09 (Reapproved 2015) | 18 Mpa minimum (Tensile Strength, After Aging) | 22.1 Mpa - 24.5 Mpa | Met | |
| ASTM D3577-09 (Reapproved 2015) | 750% minimum (Ultimate Elongation, Before Aging) | 864% - 874% | Met | |
| ASTM D3577-09 (Reapproved 2015) | 560% minimum (Ultimate Elongation, After Aging) | 727% - 734% | Met | |
| ASTM D3577-09 (Reapproved 2015) | 5.5 MPa Max (Stress at 500% before ageing) | 5.1 Mpa (Average Value) | Met | |
| Barrier Integrity | ASTM D3577-09 & ASTM D5151-06 | Max 1.5 AQL (Pinhole AQL, Before & After Aging) | 1.0 AQL (Gloves Passes) | Met |
| Chemical Residues | ASTM D6124-06 | $\le$ 2 mg/Glove (Powder Residue) | 0.26 mg/glove - 0.62 mg/glove (All sizes) | Met |
| ASTM D3577 & ASTM D5712-15 | $\le$ 50µg/dm² (Protein Content) | 38 µg/dm² | Met | |
| Biocompatibility | ISO 10993-10 | Non-irritant | Non-irritant | Met |
| ISO 10993-10 | Non-sensitizer | Non-sensitizer | Met | |
| ISO 10993-5:2009 | Non-cytotoxic | Cytotoxic | NOT Met (Qualified) | |
| ISO 10993-11:2017 | No systemic toxicity concern | No systemic toxicity concern | Met | |
| ISO 10993-11:2017 / USP 41 | No material mediated pyrogenicity response | No material mediated pyrogenicity response | Met | |
| USP 42 | NMT 20 EU/pair of gloves (Bacterial Endotoxin) |
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(413 days)
Sterile Latex Surgical Gloves, Powder Free
The Sterile Latex Surgical Gloves, Powder free, is a disposable device made of natural rubber; intended for medical purposes that is worn by operating room personnel to protect a surgical wound from contamination.
The subject device is a surgical glove made of natural rubber latex compound. It is sterile, Powder free. The device is anatomic and is hand specific. The device meets ASTM D3577 – 09 : Standard specification for Rubber Surgical Gloves. The device is for over-the counter single use.
The provided document is a 510(k) premarket notification for Sterile Latex Surgical Gloves, Powderfree. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness or performance for an AI/ML-based device.
Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device (e.g., sample size for test sets, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) is not applicable to this document.
The document primarily addresses the following for medical devices like surgical gloves:
- Acceptance Criteria & Device Performance: This section is presented as a comparison table against the predicate device and relevant ASTM/ISO standards.
- Non-Clinical Testing: The study proves the device meets acceptance criteria through various standardized tests.
Here's the relevant information extracted from the document concerning the acceptance criteria and the study proving the device meets them:
1. A table of acceptance criteria and the reported device performance
| Characteristics | Test Standard | Acceptance Criteria (from Standard) | Reported Device Performance (Sterile Latex Surgical Gloves, Powderfree) | Result |
|---|---|---|---|---|
| Freedom from Holes | ASTM D3577-09 / ASTM D5151-06 (Re-approved 2011) / FDA 1000ml water leak test | Sampling plan/Inspection level/AQL: ISO 2859-1 / G1/AQL 2.5 (for FDA 1000 ml water leak test) | PASS (for FDA 1000ml water leak test) | PASS |
| Dimensions: Length | ASTM D3577-09 | Sampling plan/Inspection level/AQL: ISO 2859-1 / S2/AQL 4.0 ; Overall length min 265 mm | > 265 mm | PASS |
| Dimensions: Width | ASTM D3577-09 | Sampling plan/Inspection level/AQL: ISO 2859-1 / S2/AQL 4.0 ; Varies from 76 mm for 6.0 size to 114 mm for 9.0 size (76±6 mm to 114±6 mm for sizes 6.0 to 9.0) | 76±6 mm to 114±6 mm (sizes 6.0 to 9.0) | PASS |
| Dimensions: Thickness | ASTM D3577-09 | Sampling plan/Inspection level/AQL: ISO 2859-1 / S2/AQL 4.0 ; Minimum 0.10mm (Cuff, palm & finger) | > 0.10 mm (Cuff, palm& finger) | PASS |
| Physical Properties: Before aging | ASTM D3577-09 and ASTM D412-06 | Sampling plan/Inspection level/AQL: ISO 2859-1 / S2/AQL 4.0 ; Tensile strength 24 Mpa min; Ultimate elongation 750% min | Tensile strength : > 24 Mpa ; Ultimate Elongation : >750% | PASS |
| Physical Properties: After Accelerated aging | ASTM D3577-09 and ASTM D573-04 | Sampling plan/Inspection level/AQL: ISO 2859-1 / S2/AQL 4.0 ; Tensile strength 18 Mpa min; Ultimate elongation 560 % min | Tensile strength : > 18 Mpa ; Ultimate Elongation : > 560% | PASS |
| Powder-free residue | ASTM D3577-09 and ASTM D6124-06 | Sampling plan: N=5 ; Less than 2 mg per glove | Less than 2 mg per glove | PASS |
| Biocompatibility: Primary skin irritation | ISO 10993-10 | Under the conditions of the study the device is not an irritant | Under the conditions of the study the device is not an irritant | PASS |
| Biocompatibility: Skin Sensitization | ISO 10993-10 | Under the conditions of the study the device is not a sensitizer | Under the conditions of the study the device is not a sensitizer | PASS |
| Sterility | ISO-11737-2 | Sterile | Sterile | PASS |
| EO Residue | ISO 10993-07:2008 | Maximum limit of EO Residue : 0.0025mg/device | Meets | Meets |
| ECH Residue | ISO 10993-07:2008 | Maximum limit of ECH Residue : 0.0025mg/device | Meets | Meets |
| Expiration dating/Shelf life | ASTM D7160-05 | Not explicitly stated in criteria table, but mentioned as "Three years" | Three years | Meets |
| Sterilization | ISO 11135-2014(E) | Requirements for the development, validation and routine control of a sterilization process for medical devices | Meets | Meets |
2. Sample size used for the test set and the data provenance
- Sample Sizes: Sample sizes are indicated within the "Sampling plan / Inspection level / AQL" columns in the performance data table (e.g., ISO 2859-1 / G1 / AQL 2.5, ISO 2859-1 / S2 / AQL 4.0, N=5 for powder-free residue). For the specific Freedom from Pinholes test, it notes: "Lot Size : 35001 – 150000 pair; Sample size : 200 pair".
- Data Provenance: Not explicitly stated as "country of origin" or "retrospective/prospective" in the context of clinical studies, as this is laboratory/manufacturing performance data. The manufacturer is SANREA HEALTHCARE PRODUCTS PVT LTD, located in Palakkad, Kerala, India.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable: This type of testing involves laboratory and physical property measurements against established international standards (ASTM, ISO, FDA). "Ground truth" in this context is defined by the technical specifications and methodologies of these standards, not expert adjudication of medical images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: As above, this pertains to physical and chemical testing against defined standard metrics.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable: This is a premarket notification for a Class I medical device (surgical gloves), not an AI/ML-based diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Standardized Test Methods and Specifications: The "ground truth" for the performance of these gloves is defined by the requirements and test methodologies outlined in the referenced ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards (e.g., ASTM D3577-09 for rubber surgical gloves, ASTM D5151-06 for freedom from holes, ISO 10993 for biocompatibility, ISO 11135 for sterilization). The FDA 1000ml water leak test is also mentioned.
8. The sample size for the training set
- Not Applicable: There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not Applicable: There is no "training set" as this is not an AI/ML device.
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