(169 days)
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Not Found
No
The summary describes standard surgical gloves and their physical properties, with no mention of AI or ML technology.
No
The gloves are intended to protect a surgical wound from contamination, not to treat a medical condition or disease.
No
This device is a surgical glove, intended to protect a surgical wound from contamination, not to diagnose a medical condition.
No
The device description clearly identifies the device as "Sterile Powder-Free Synthetic Polyisoprene Surgical Gloves," which are physical hardware. There is no mention of software components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the gloves are "intended to be worn by operating room personnel to protect a surgical wound from contamination." This describes a barrier function for protection during a medical procedure.
- Device Description: The description focuses on the physical properties and standards met by the gloves (dimensions, physical properties, freedom from holes, powder-free). These are characteristics of a physical barrier device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are used in vitro (outside the body) to analyze samples.
This device is a medical glove, which is a type of medical device, but not an IVD.
N/A
Intended Use / Indications for Use
These gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination.
Product codes
KGO
Device Description
Derma Prene® PI or Isotouch® Green Sterile Powder-Free Synthetic Polyisoprene Surgical Gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating room 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
The performance test data of the non-clinical tests are the same as mentioned immediately above.
- Clinical data is not needed for medical gloves or for most devices cleared by the 510(k) process.
It is concluded that Derma Prene® PI or Isotouch® Green Sterile Powder-Free Synthetic Polyisoprene Surgical Gloves are as safe, as effective, and perform as well as the glove performance standards referenced in Section 7 above and therefore meet:
ASTM listed standards, FDA hole requirements, and labeling claims for the product.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Ansell
[1] 510(k) SUMMARY
- [2] Ansell Healthcare Products LLC 1635 Industrial Road Dothan, AL 36303
DEC 1 3 2007
| Contact: | Lon D. McIlvain
Vice President, Regulatory and Quality Affairs, Global |
|------------|---------------------------------------------------------------------------|
| Telephone: | (334) 615-2562 |
| Fax: | (334) 615-2568 |
June 25, 2007
- Derma Prene® PI or Isotouch® Green Sterile Powder-Free . [3] Trade Name: Synthetic Polyisoprene Surgical Gloves
Common Name: Surgical Gloves
Classification Name: Surgeon's Gloves, powder-free (21 CFR §878.4461 proposed)
- [4] Derma Prene® PI or Isotouch® Green Sterile Powder-Free Synthetic Polyisoprene Surgical Gloves meet all of the requirements of ASTM D 3577-06, Type 2.
- [5] Derma Prene® PI or Isotouch® Green Sterile Powder-Free Synthetic Polyisoprene Surgical Gloves meet all of the current specifications of ASTM D 3577-06, Type 2.
- Derma Prene® PI or Isotouch® Green Sterile Powder-Free Synthetic Polyisoprene [6] Surgical Gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination.
- [7] Derma Prene® PI or Isotouch® Green Sterile Powder-Free Synthetic Polyisoprene Surgical Gloves are summarized with the following technological characteristics compared to ASTM or equivalent standards.
| Characteristics | Standard |
|---|---|
| Dimensions | |
| Physical Properties | Meets ASTM D 3577 |
| Meets ASTM D 3577, Type 2 | |
| Freedom from Holes | Meets ASTM D 3577 |
| Meets ASTM D 5151 | |
| Powder Free | Meets ASTM D 6124 |
IS AS I M D 0 Powder content = 2 mg per glove
1
Biocompatibility:
[8]
FHSA Skin Irritation Study ISO Maximization Sensitization Study Cytotoxicity Study using the End-Point Titration Method
Passes Passes
Non-Toxic at 24 hours
The performance test data of the non-clinical tests are the same as mentioned immediately above.
- Clinical data is not needed for medical gloves or for most devices cleared by the [9] 510(k) process.
It is concluded that Derma Prene® PI or Isotouch® Green Sterile Powder-Free (10) Synthetic Polyisoprene Surgical Gloves are as safe, as effective, and perform as well as the glove performance standards referenced in Section 7 above and therefore meet:
ASTM listed standards, FDA hole requirements, and labeling claims for the product.
- This summary will include any other information reasonably deemed necessary by the [1] FDA.
2
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health and Human Services. The seal features an eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the symbol.
DEC 1 3 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ansell Healthcare Products, LLC Ms. Cynthia A. Ingram Regulatory Affairs Manager, Americas 1635 Industrial Road Dothan, Alabama 36303
Re: K071746
Trade/Device Name: Derma Prene® PI or Isotouch® Green Sterile Powder-Free Synthetic Polyisoprene Surgical Gloves Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: November 29, 2007 Received: November 30, 2007
Dear Ms. Ingram:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Ms. Ingram
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chris Liu, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(K) Number (if known):
Device Name:
Derma Prene® PI or Isotouch® Green Sterile Powder-Free Synthetic Polyisoprene Surgical Gloves
Indications For Use:
These gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Stele H. Murphy, MD
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
-10-