(218 days)
Not Found
Not Found
No
The device description and intended use clearly describe a standard medical glove, with no mention of AI/ML capabilities or related technologies.
No
The device, a surgical glove, is intended to prevent contamination, not to treat a disease or condition in a patient.
No
Explanation: The device, a medical glove, is intended to prevent contamination between healthcare personnel and patients, not to diagnose any condition or disease.
No
The device description clearly states it is a "Latex patient surgeons 'gloves powderfree", which is a physical hardware device. There is no mention of software as the primary component or function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between healthcare personnel and the patient by being worn on the hand. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description is of a physical glove.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This glove does not fit that description.
N/A
Intended Use / Indications for 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
This medical glove is worn on the hand of surgeons, nurses and similar personnel to prevent contamination between health care personnel and the patient.
Product codes (comma separated list FDA assigned to the subject device)
80 FPI, 79KGO
Device Description
Latex patient surgeons 'gloves powderfree
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons, nurses and similar personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Quality characteristics acc. ASTM D3577-91
8.2 Sterility Test: Periodical Validation of the process with Bioservice scientific Laboratories - Germany
8.3 Freedom from holes: Sampling acc. ISO 2859 (att. 9 - 14/13) AQL 1,0
8.4 Physical Dimension Test: 2. Length 270 - 280 mm related to glove size; 3. Width 6, 6,5, 7, 7,5, 8, 8,5, 9; 4. Thickness: 017 - 0,26 mm
8.5 Physical Requirement Test: Before Aging (Tensile Strength MPa, min 24; Ultimate Elongation % 750; Stress at 500 % Elongation 5.5); After Aging (Tensile Strength MPa 18; Ultimate Elongation % 560
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
AQL 1,0, Tensile Strength MPa, Ultimate Elongation %, Stress at 500 % Elongation
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
7.2 Quality characteristics acc. ASTM D3577-91
| Description acc. ASTM items | ||||||||
|---|---|---|---|---|---|---|---|---|
| 8.2 Sterility Test | Periodical Validation of the process with | |||||||
| Bioservice 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 Physical | ||||||||
| Dimension | ||||||||
| Test | 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 Physical | ||||||||
| Requirement | ||||||||
| Test | Before Aging | After Aging | ||||||
| Tensile | ||||||||
| Strength | ||||||||
| MPa, min | Ultimate | |||||||
| Elongation % | Stress at | |||||||
| 500 % | ||||||||
| Elongation | Tensile | |||||||
| Strength | ||||||||
| MPa | Ultimate | |||||||
| Elongation % | ||||||||
| 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
2
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.
3
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
4
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
Image /page/4/Picture/2 description: The image shows the word "SEMPERIT" in large, bold, black letters on the top line. Below that, in a smaller font size, is the phrase "Technische Produkte" also in black letters. The text appears to be a logo or heading, possibly for a company or product line.
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: | Latex |
| Sempermed Surgeons' Gloves - Supreme, Powder Free | |
| Indications For 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. |
(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