Search Results
Found 2 results
510(k) Data Aggregation
(115 days)
Allmed Medical (Hubei) Protective Products Co., Ltd
The proposed surgical gowns are intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the surgical gowns met the requirements for Level 3 classification.
Non-sterile gowns are to be sold to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135-1 prior to marketing to the end users and sterile surgical gowns are to be sold directly to the end users after EtO sterilization validation to ISO 11135-1.
The proposed surgical gowns are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. The proposed devices are single use, disposable medical devices and can be provided in sterile two types. Both the sterile and non-sterile surgical gowns are blue colored and available in six sizes, including S, M. L, XL, XXL and XXXL. For non-sterile surgical gowns, they shall be sterilized by EO prior to use.
The proposed surgical gowns are constructed of a SMS nonwoven material (spunbond +meltblown + spunbond nonwovens) and has been tested according to ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities and meets AAMI Level 3. It is a kind of non-reinforced surgical gown.
Here's a breakdown of the acceptance criteria and the study details for the Surgical Gown device (K221637), based on the provided document:
Acceptance Criteria and Device Performance
| Testing Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Performance Testing | |||
| Hydrostatic Pressure (AATCC 127-2018) | To measure the resistance of a fabric to the penetration of water under hydrostatic pressure | ≥50cm H2O | Passed. 3 non-consecutive lots tested, using a sample size of 32/lot. All parts of test specimen met the Level 3 requirements. |
| Water Resistance (AATCC 42-2017) | To verify the impact penetration of the device. | ≤1.0g | Passed. 3 non-consecutive lots tested, using a sample size of 32/lot. All parts of test specimen met the Level 3 requirements. |
| Tearing Strength (ASTM D5587-15 (2019)) | To determine the tearing strength of the device. | ≥10N | Passed. Sample size of 10 pcs. MD Mean: 34.39N, CD Mean: 18.06N. |
| Breaking Strength (ASTM D5034-09 (2017)) | To determine the breaking strength and elongation of the device. | ≥30N | Passed. Sample size of 10 pcs. MD Mean: 138.64N, CD Mean: 75.10N. |
| Seam Strength (ASTM D1683/D1683M-17(2018)) | To measure the sewn seam strength in surgical gown by applying a force perpendicular to the sewn seams | ≥30N | Passed. Sample size of 10 pcs. Mean 57.56 N. |
| Evaporative Resistance (ASTM F1868-17) | To measure the evaporative resistance under steady-state conditions of fabrics of the device. | ≤1.0kPa·m²/W | Passed. Sample size of 3pcs. 0.00315 kPa • m²/W. |
| Lint and other particles generation in the dry state (ISO 9073-10-2003) | To measure the linting of non-woven in the dry state. | Coefficient of linting Log₁₀≤4.0 | Passed. Sample size of 10pcs. Log₁₀ Mean: 2.7. |
| Flammability (16 CFR 1610) | To determine the flammability of textiles for the surgical gowns. | Class I | Passed. Sample size of 5 pcs. All samples are Class I. |
| Biocompatibility Testing | |||
| Cytotoxicity | Assess the potential risk of cytotoxicity of surgical gown material | Non-cytotoxic | Passed. Under the condition of this study, the device has no potential toxicity. |
| Irritation | Assess the potential risk of irritation of surgical gown material | Negligibly irritating | Passed. Under the condition of this study, the device is negligibly irritating. |
| Sensitization | Assess the potential risk of sensitization of surgical gown material | Non-sensitizing | Passed. Under the conditions of the study, the device is non-sensitizing. |
| Ethylene Oxide Residuals | Verify low levels of sterilant residuals | EO residual |
Ask a specific question about this device
(128 days)
Allmed Medical (Hubei) Protective Products Co., Ltd
The Isolation Gowns are intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, The Isolation Gowns meet the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The Isolation Gowns are a single use, disposable medical non-sterile.
The Isolation Gown is a surgical isolation gown with moderate barrier protection identified by Regulation 21 CFR 878.4040 under FDA product code, FYC. The Isolation Gown is offered in two colors (yellow and blue) and each color is offered in five sizes (S, M, L, XL and XXL) for a total of ten models. Each model is constructed of a SMS nonwoven material (spunbond +meltblown + spunbond nonwovens) and has been tested according to ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities and meets AAMI Level 3. The Isolation Gown is a single use, disposable medical device that will be provided in a variety of non-sterile packaging configurations.
The provided text describes the acceptance criteria and the results of non-clinical tests for an Isolation Gown. This is a medical device, specifically protective apparel, and not an AI/ML device. Therefore, the questions related to AI/ML device studies, such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types, are not applicable to this document.
Here's the relevant information based on the provided text for the Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)):
1. A table of acceptance criteria and the reported device performance
| Test Item | Test Standard | Acceptance Criteria for Level 3 Barrier | Result of Yellow Isolation Gown XXL | Result of Blue Isolation Gown XXL |
|---|---|---|---|---|
| Water Resistance: Hydrostatic Pressure Test | AATCC 127-2018e | ≥50 cmH2O per standard ANSI/AAMI PB70:2012 for level 3 | Passed | Passed |
| Water Resistance: Impact Penetration Test | AATCC 42-2017 | ≤1.0g AQL: 4% Level 3 per standard ANSI/AAMI PB70:2012 for level 3 | Passed | Passed |
| Breaking Strength and Elongation | ASTM D 5034-2009 (2017) | ≥30N(7lbf) | Passed | Passed |
| Tearing Strength | ASTM D 5587-2015 | ≥10N (2.3 lbf) | Passed | Passed |
| Seam Strength | ASTM D1683/D1683M-2017 (2018) | ≥30N (7lbf) | Passed | Passed |
| Lint and other particles generation in the dry state | ISO 9073-10:2003 | Reported Data | Total linting: Avg 187; Coeff of linting: Avg 2.3 | Total linting: Avg 584; Coeff of linting: Avg 2.8 |
| Thermal and Evaporative Resistance | ASTM F 1868-2017 | Reported Data | Evaporative resistance: 0.00217 | Evaporative resistance: 0.00198 |
| Flammability Test | 16 CFR Part 1610 | Class I | Passed | Passed |
| Mass Per Unit Area | ISO 9073-1:1989 | Reported Data | 39.56 | 40.62 |
| Biocompatibility: Cytotoxicity | ISO 10993-5 | Non-cytotoxic | Non-cytotoxic | Non-cytotoxic |
| Biocompatibility: Sensitization | ISO 10993-10 | Non-sensitizing | Non-sensitizing | Non-sensitizing |
| Biocompatibility: Irritation | ISO 10993-10 | Negligibly irritating | Negligibly irritating | Negligibly irritating |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes for each specific test but indicates that tests were performed on "Yellow Isolation Gown XXL" and "Blue Isolation Gown XXL". The tests are non-clinical, related to material properties of the gown. Data provenance (country of origin, retrospective/prospective) is not provided as this is an evaluation of a physical medical device, not a data-driven model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a physical medical device (isolation gown), not an AI/ML device relying on expert interpretation for ground truth. Ground truth is established by physical and chemical testing standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a physical medical device, not an AI/ML device requiring adjudication of results.
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 physical medical device, not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth is based on established international and national standards for performance and safety of protective apparel and medical devices. Specifically:
- ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended For Use In Health Care Facilities (for liquid barrier performance)
- AATCC 127-2018e (Water Resistance: Hydrostatic Pressure Test)
- AATCC 42-2017 (Water Resistance: Impact Penetration Test)
- ASTM D 5034-2009 (2017) (Breaking Strength and Elongation)
- ASTM D 5587-2015 (Tearing Strength)
- ASTM D1683/D1683M-2017 (2018) (Seam Strength)
- ISO 9073-10:2003 (Lint and other particles generation)
- ASTM F 1868-2017 (Thermal and Evaporative Resistance)
- 16 CFR Part 1610 (Flammability Test)
- ISO 9073-1:1989 (Mass Per Unit Area)
- ISO 10993-1:2018, ISO 10993-5, ISO 10993-10 (Biocompatibility)
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device, not an AI/ML device that requires a training set with established ground truth.
Ask a specific question about this device
Page 1 of 1