(65 days)
Not Found
No
The device description and intended use clearly define the device as surgical gloves, with no mention of AI or ML capabilities. The document explicitly states "Mentions AI, DNN, or ML: Not Found".
No.
The device is a surgical glove intended for protection and contamination prevention, not for treating or diagnosing a disease or condition.
No
The device, Elite™ Powder Free Polyurethane Synthetic Surgical Gloves, is intended to protect a surgical wound from contamination and for handling chemotherapy drugs, not for diagnosing medical conditions.
No
The device description clearly states it is made of synthetic rubber and is a physical glove, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect a surgical wound from contamination and for handling chemotherapy drugs. This is a protective barrier function, not a diagnostic test performed on samples taken from the human body.
- Device Description: The description focuses on the physical properties and standards met by surgical gloves. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no indication of a diagnostic purpose or the use of reagents or instruments for in vitro analysis.
Therefore, this device falls under the category of a medical device, specifically a surgical glove, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Elite™ Powder Free Polyurethane Synthetic Surgical Gloves (Chemotherapy Use) are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination and for use handling chemotherapy drugs.
A device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination and for use handling chemotherapy drugs.
Product codes
KGO
Device Description
Elite™ Powder Free Polyurethane Synthetic Surgical Gloves (Chemotherapy Use), meet all of the requirements of ASTM D 3577, Type 2.
Elite™ Powder Free Polyurethane Synthetic Surgical Gloves (Chemotherapy Use) meet all the current specifications for ASTM D 3577 Rubber Surgical Gloves.
Elite™ Powder Free Polyurethane Synthetic Surgical Gloves (Chemotherapy Use) are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination and for use handling chemotherapy drugs.
Elite™ Powder Free Polyurethane Synthetic Surgical Gloves (Chemotherapy Use) are summarized with the following technological characteristics compared to ASTM or equivalent standards.
| Characteristics | Standard |
|---|---|
| Dimensions | Meets ASTM D 3577 |
| Physical Properties | Meets ASTM D 3577, Type 2 |
| Freedom from holes | Meets ASTM D 3577, Meets ASTM D 5151 |
| Powder-Free | Meets described test in Attachment VI of K973461 Not more than 2 mg residue by mass. |
| Biocompatability | Primary Skin Irritation in Rabbits Passes |
| Guinea Pig Sensitization Passes |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 Elite™ Powder Free Polyurethane Synthetic Surgical Gloves (Chemotherapy Use) 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 (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
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
2/26/99
Ansell Perry
Elite™ Powder Free Polyurethane Synthetic Surgical Gloves (Chemotherapy Use) Ansell Perry 1875 Harsh Avenue SE Massillon, Ohio 44646 330-833-2811 Telephone: 330-833-6213 Fax:
Checklist Section 21.0
- 510 (k) Summary [1]
- [2] Ansell Perry Inc. 1875 Harsh Avenue SE Massillon, Ohio 44646
330-833-2811 Telephone: 330-833-6213 Fax:
James R. Chatterton Contact: 330-833-2811 Telephone: Fax: 330-833-6213
December 23, 1998
- Trade Name: Elite™ Powder Free Polyurethane Synthetic Surgical Gloves (Chemotherapy Use) [3] Surgical Gloves, Green Polyurethane Common Name: Classification Name: Surgeon's Glove
- Elite™ Powder Free Polyurethane Synthetic Surgical Gloves (Chemotherapy Use), meet all of [4] the requirements of ASTM D 3577, Type 2.
- Elite™ Powder Free Polyurethane Synthetic Surgical Gloves (Chemotherapy Use) meet all the [ર] current specifications for ASTM D 3577 Rubber Surgical Gloves.
- Elite™ Powder Free Polyurethane Synthetic Surgical Gloves (Chemotherapy Use) are sterile િશ disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination and for use handling chemotherapy drugs.
- [7] Elite™ Powder Free Polyurethane Synthetic Surgical Gloves (Chemotherapy Use) are summarized with the following technological characteristics compared to ASTM or equivalent standards.
| Characteristics | Standard |
|---|---|
| Dimensions | Meets ASTM D 3577 |
| Physical Properties | Meets ASTM D 3577, Type 2 |
Ansell Healthcare Products Inc. • 1875 Harsh Ave. S.E. • Massillon, Ohio 44646 • U.S.A. http://www.amsell.com Telephone: 330-833-2811 • Toll Free: 800-321-9752 (USA only) • Fax: 330-833-5991
1
Elite™ Powder Free Polyurethane Synthetic Surgical Gloves (Chemotherapy Use) Ansell Perry 1875 Harsh Avenue SE Massillon, Ohio 44646 330-833-2811 Telephone: 330-833-6213 Fax:
Freedom from holes
.)
Meets ASTM D 3577 Meets ASTM D 5151
Powder-Free Meets described test in Attachment VI of K973461 Biocompatability Primary Skin Irritation in Rabbits Guinea Pig Sensitization
Meets ASTM D 6124 Not more than 2 mg residue by mass.
Passes Passes
- The performance test data of the non clinical tests are the same as mentioned immediately above. [8]
- (9) Clinical data is not needed for medical gloves or for most devices cleared by the 510(k) process.
- [10] It is concluded that Elite™ Powder Free Polyurethane Synthetic Surgical Gloves (Chemotherapy Use) 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.
- [11] This summary will include any other information reasonably deemed necessary by The FDA.
2
Image /page/2/Picture/1 description: The image contains the words "Public Health Service" in bold, black font. The words are stacked on top of each other, with "Public Health" on the top line and "Service" on the bottom line. The text appears to be extracted from a document or sign.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 26 1999
Mr. James R. Chatterton Vice President Regulatory Affairs/Technical Ansell Perry, Incorporated 1875 Harsh Avenue S.E. Massillon, Ohio 44646-7199
K984559 Re : Elite Powder-Free Polyurethane Synthetic Trade Name: Surgical Gloves (Chemotherapy Use) Requlatory Class: I Product Code: KGO Dated: December 23, 1998 December 23, 1998 Received:
Dear Mr. Chatterton:
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 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). You may, therefore, market the device, subject to the general The general controls controls provisions of the Act. 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. 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
3
Page 2 - Mr. Chatterton
through 542 of the Act for devices under the Electronic enrough Size of Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA deborizon substantial equivalence of your device to a legally Finding of babboandable results in a classification for your marketed production of mits 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" (21CFR 807.97). Other general 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/dsma/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 Radioloqical Health
Enclosure
4
3.0 Indications for Use Statement:
510(K) Number (if known): __
INDICATIONS FOR USE
Ansell Perry Applicant: 1698 4559
Elite™ Powder-Free Polyurethane Synthetic Surgical Gloves (Chemotherapy Use) Device Name: _ Indications For Use:
A device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination and for use handling chemotherapy drugs.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Clim S. Lin
(Division Sign Off)
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
Prescription Use Per 21 CFR 801.109 OR
Over-The-Counter