(218 days)
This medical glove is worn on the hand of surgeons, nurses and similar personnel to prevent contamination between health care personnel and the patient.
Latex patient surgeons 'gloves powderfree
Here's a breakdown of the acceptance criteria and study information for the Sempermed Latex Surgeons' Gloves, Powder-Free device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document refers to meeting ASTM Standard D 3577-91 and EN 455/1-3 as the primary acceptance criteria. Specific performance items are listed under "Quality characteristics acc. ASTM D3577-91".
| Description acc. ASTM items | Acceptance Criteria (Spec) | Reported Device Performance |
|---|---|---|
| Sterility Test | Periodical Validation of the process | Validated by Bioservice scientific Laboratories - Germany |
| Freedom from holes | AQL 1.0 (Sampling acc. ISO 2859) | Meets and exceeds FDA pinhole requirements (AQL 1.0) |
| Physical Dimension Test | ||
| 2. Length | 270 - 280 mm related to glove size | (Implied to meet, no specific deviation reported) |
| 3. Width | See table below for glove sizes | (Implied to meet, no specific deviation reported) |
| Glove Size 6 | 79 ±2 mm | (Implied to meet) |
| Glove Size 6.5 | 84 ±3 mm | (Implied to meet) |
| Glove Size 7 | 89 ±3 mm | (Implied to meet) |
| Glove Size 7.5 | 97 ±3 mm | (Implied to meet) |
| Glove Size 8 | 104 ±3 mm | (Implied to meet) |
| Glove Size 8.5 | 110 ±3 mm | (Implied to meet) |
| Glove Size 9 | 114 ±3 mm | (Implied to meet) |
| 4. Thickness | 0.17 - 0.26 mm | (Implied to meet, no specific deviation reported) |
| Physical Requirement Test (Before Aging) | ||
| Tensile Strength MPa, min | 24 MPa | (Implied to meet) |
| Ultimate Elongation % | 750 % | (Implied to meet) |
| Physical Requirement Test (After Aging) | ||
| Stress at 500 % Elongation | 5.5 | (Implied to meet) |
| Tensile Strength MPa | 18 MPa | (Implied to meet) |
| Ultimate Elongation % | 560 % | (Implied to meet) |
| Immunological RAST-inhibition test | (Implied to meet standard, see attached test results) | (See attached test results) |
| Skin irritation test on rabbits | (Implied to meet standard, see attached test results) | (See attached test results) |
| Maximization test/Sensibilisation of skin on genuine-pig | (Implied to meet standard, see attached test results) | (See attached test results) |
Notes on "Reported Device Performance": The document states "Sempermed powderfree surgeons gloves Supreme meets ASTM D 3577-91 and EN 455 standard but exceed FDA pinhole requirements (AQL 1,0)." This implies all listed criteria were met or exceeded, even if specific numerical results are not provided in this summary. The mention of attached test results further supports this.
Regarding Specific Study Details (as requested):
This document describes a 510(k) submission for a medical glove, which is a Class I device. The nature of testing for such devices, especially prior to 1998, focuses on compliance with established standards (like ASTM and EN) rather than complex clinical studies or AI-driven performance evaluations. Therefore, many of the requested details about advanced studies (like MRMC, standalone AI performance, large ground truth expert panels, and specific sample sizes for training/test sets common in AI submissions) are not applicable to this type of device and submission.
Here's an attempt to address the requested points based on the available information:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not explicitly stated as a single "test set" in the context of AI evaluation. For "Freedom from holes," it mentions "Sampling acc. ISO 2859 (att. 9 - 14/13)". ISO 2859 refers to acceptance sampling procedures, which involve statistical sampling plans to assess quality characteristics. The number of gloves sampled would depend on the lot size and the specific sampling plan used under ISO 2859.
- Data Provenance: The document refers to "Bioservice scientific Laboratories - Germany" for sterility testing. It's likely that other physical and chemical tests were performed internally by Semperit or by other specialized laboratories. The general provenance is Austria (Semperit's location) and Germany (for sterility).
- Retrospective or Prospective: This distinction is not relevant for the type of device testing described. These are laboratory-based, prospective tests on manufactured products.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. The "ground truth" for the performance of these gloves is defined by the technical specifications of ASTM D 3577-91 and EN 455/1-3. Compliance is determined by objective physical, chemical, and sterility tests, not by human expert consensus or clinical judgment on a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None. Adjudication methods are used when there's subjective interpretation involved, typically in imaging or diagnostic AI. The tests for these gloves are objective measurements.
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:
- No. MRMC studies are for evaluating the impact of AI on human diagnostic performance. This device is a physical product (surgical glove), not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" is established by objective measurement against predefined physical, chemical, and sterility standards (ASTM D 3577-91 and EN 455/1-3). For example, "Freedom from holes" has a numerical definition (AQL 1.0) and "Tensile Strength" has a minimum MPa value.
8. The sample size for the training set:
- Not Applicable. There is no "training set" in the context of an AI device for this submission. The manufacturing process of gloves is controlled to meet these standards.
9. How the ground truth for the training set was established:
- Not Applicable. As there's no training set for an AI model, this question is not relevant. The standards themselves were established by expert committees (e.g., ASTM, CEN) through scientific and technical consensus over time.
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SEMPERIT TECHNISCHE PRODUKTE GES.M.B.H. Bundesstraße 26, A-2632 Wimpassing Tel.: ++43 2630 310 308, FAX: ++43 2630 310 479
510 (k) Summary
14.03.1998
1.0 APPLICANT Semperit Technische Produkte Ges.m.b.H. Modecenterstraße 22 A-1031 Vienna Phone: ++43 1 79777 490 ++43 1 79777 630 Fax:
- 2.0 CONTACT PERSON
Dipl.-Ing. R. Ehrenfeldner Semperit Technische Produkte Ges.m.b.H. Bundesstraße 26 A-2632 Wimpassing Phone: ++43 2630 310 216 ++43 2630 310 479 Fax:
Semperit Industrial Prod. Inc. Mr. Manfred Reichel 220 Kinderkamack Road Suite B. Westwood NJ Phone: (201) 664 5222 (800) 631 2566 (201) 664 6688 Fax:
- 3.0 Device Class: I Type 1 Product Code: 80 FPI/878.4460 (79KGO)
- Latex patient surgeons gloves 4.0 Specification: powederfree - Class I 80 FPI Type 1 meets all of the requirements of ASTM Standard D 3577-91 and EN 455/1-3
- 5.0 Device Description: Latex patient surgeons 'gloves powderfree
- 6.0 Intended use: This medical glove is worn on the hand of surgeons, nurses and similar personnel to prevent contamination between health care personnel and the patient. Supreme is a powderfree glove with an additional inner layer to make donning easily possible (MC = multilayer coating) and TUV-Productservice claim. (see attachement 1 and 2)
- 7.1 Surface treatment: Single side polymer coated, halogenation, siliconization and extensive washing with water in 8 steps. Inside and outside free from glove powder and free of talc. (see att. 9 - 12/6.1 and 6.2)
300/HAQ
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7.2 Quality characteristics acc. ASTM D3577-91
| Description acc. ASTM items | ||||||||
|---|---|---|---|---|---|---|---|---|
| 8.2 Sterility Test | Periodical Validation of the process withBioservice scientific Laboratories - Germany(attachement 8.2.1/8.2.2) | |||||||
| 8.3 Freedom from holes | Sampling acc. ISO 2859 (att. 9 - 14/13)AQL 1,0 | |||||||
| 8.4 PhysicalDimensionTest | 2. Length 270 - 280 mm related to glove size | |||||||
| 3. Width | 6 | 6,5 | 7 | 7,5 | 8 | 8,5 | 9 | |
| 79 ±2 | 84 ±3 | 89 ±3 | 97 ±3 | 104 ±3 | 110 ±3 | 114 ±3 | ||
| 4. Thickness: 017 - 0,26 mm | ||||||||
| 8.5 PhysicalRequirementTest | Before Aging | After Aging | ||||||
| TensileStrengthMPa, min | UltimateElongation % | Stress at500 %Elongation | TensileStrengthMPa | UltimateElongation % | ||||
| Spec | 24 | 750 | 5.5 | 18 | 560 |
Internal microscopic method 10 pow
8 + 9.1 Immunological RAST-inhibition test
- 8 + 9.2 Skin irritation test on rabbits
- 8 + 9.3 Maximization test/Sensibilisation of skin on genuine-pig See attached test resultas (attachement 9 - 14/7, 9 - 14/1 - 6)
-
- Conclusion
Sempermed powderfree surgeons gloves Supreme meets ASTM D 3577-91 and EN 455 standard but exceed FDA pinhole requirements (AQL 1,0). It meets the labelling claims as shown by attachements 1(2), 9 - 12/6.1 und 6.2, 9 - 14/13, 9 - 12/6.1/2
} 9-14 chapt.
1-3 p pages
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Image /page/2/Picture/10 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which consists of three stylized human profiles facing to the right, stacked on top of each other. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 9 1998
Mr. Richard Ehrenfeldner Semperit Technische Produkte Gesellschaft m.b.H. Triester Bundesstrabe 26 A-2632 Wimpassing
Re : K981096 Sempermed Latex Surgeons' Gloves, Powder-Trade Name: Free Regulatory Class: I Product Code: KGO Dated: August 18, 1998 Received: August 21, 1998
Dear Mr. Ehrenfeldner:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Ehrenfeldner
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda/gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Semperit Technische Produkte Gesellschaft m.b.H.
A-2632 Wimpassing, Triester Bundesstraße 26 Telefon (02630) 310/216 Telex 16 óól semp a Telekopierer 02630/310/479
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INDICATIONS FOR USE
Image /page/4/Picture/4 description: The image shows a document with some text and a stamp. The text on the document reads "CRH/OCE/CHC" and "21 AUG 83 206 13". There is also a stamp on the document that says "RELEASED".
| Applicant: | Semperit Technische Produkte Ges.m.b.H. |
|---|---|
| 510(k) Number (if known): | K 98 10 96 |
| Device Name: | LatexSempermed Surgeons' Gloves - Supreme, Powder Free |
| Indications For Use: | This medical glove is worn on the hand of surgeons, nurses andsimilar personnel to prevent contamination between health carepersonnel and the patient. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrenze of CDRH Office of Device Evalution (ODE)
Olin S. L
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
Prescription Use Per 21 CFR 081.109
OR
Over-The-Counter
- For a new submission, do NOT fill in the 510(k) number blank.
(Optional Format 1-2-96)
مزمد سنده
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).