(49 days)
There are no Predicate Device(s) K/DEN numbers listed in the provided text. The section "Predicate Device(s)" states "Not Found".
Not Found
No
The document describes standard surgical gloves and makes no mention of AI or ML technology.
No.
The device's intended use is to protect a surgical wound from contamination, not to treat or therapeutically benefit a patient.
No
The device is described as surgical gloves intended to protect a surgical wound from contamination, not to diagnose a condition.
No
The device description clearly states it is made of natural rubber and is a physical glove, not software.
No, 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 by being worn by operating room personnel. This is a physical barrier function, not a diagnostic test performed on a sample from the human body.
- Device Description: The description focuses on the physical properties and standards met by the surgical gloves (ASTM D 3577). There is no mention of analyzing samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
This device is clearly a medical device intended for physical protection and barrier function in a surgical setting.
N/A
Intended Use / Indications for Use
A device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Product codes
KGO
Device Description
Encore Mark IV Powder Free Surgical Gloves, meet all of the requirements of ASTM D 3577, Type 1. Encore Mark IV Powder Free Surgical Gloves meet all the current specifications for ASTM D 3577 Rubber Surgical Gloves. Encore Mark IV Powder Free Surgical Gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination. Encore Mark IV Powder Free Surgical Gloves are summarized with the following technological characteristics compared to ASTM or equivalent standards: Dimensions meet ASTM D 3577; Physical Properties meet ASTM D 3577, Type; Freedom from holes meets ASTM D 3577, meets ASTM D 5151; Powder-Free meets ASTM D 6124, Not more than 2 mg residue by mass, Meets described test in Attachment VI; Biocompatibility: 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
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 Encore Mark IV Powder Free 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
Encore Mark IV Powder Free Surgical Gloves Ansell Perry 1875 Harsh Avenue SE Massillon, Ohio 44646 Telephone: 330-833-2811 330-833-6213 Fax:
FEB - 9 1998
Checklist Section 21.0
- [1] 510 (k) Summary
- [2] Ansell Perry Inc. 1875 Harsh Avenue SE Massillon, Ohio 44646
Telephone: 330-833-2811 Fax: 330-833-6213
James R. Chatterton Contact: Telephone: 330-833-2811 Fax: 330-833-6213
December 18, 1997
- Encore Mark IV Powder Free Surgical Gloves [3] Trade Name: Common Name: Surgical Gloves Classification Name: Surgeon's Glove
- [4] Encore Mark IV Powder Free Surgical Gloves, meet all of the requirements of ASTM D 3577, Type 1.
- Encore Mark IV Powder Free Surgical Gloves meet all the current specifications for ASTM D [ર] 3577 Rubber Surgical Gloves.
- [6] Encore Mark IV Powder Free Surgical Gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination.
- [7] Encore Mark IV Powder Free Surgical Gloves 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 |
1
| | Encore Mark IV Powder Free Surgical Gloves
Ansell Perry
1875 Harsh Avenue SE
Massillon, Ohio 44646 | |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------|------------------------------------|
| | Telephone: | 330-833-2811 |
| | Fax: | 330-833-6213 |
| Freedom from holes | Meets ASTM D 3577 | Meets ASTM D 5151 |
| Powder-Free | Meets ASTM D 6124 | Not more than 2 mg residue by mass |
| Meets described test in Attachment VI | | |
| Biocompatability | | |
| Primary Skin Irritation in Rabbits | | Passes |
| Guinea Pig Sensitization | | Passes |
- The performance test data of the non clinical tests are the same as mentioned immediately above. [8]
- Clinical data is not needed for medical gloves or for most devices cleared by the 510(k) process. [9]
- It is concluded that Encore Mark IV Powder Free Surgical Gloves are as safe, as effective, and [10] 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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FFB - 8 1958
Mr. James R. Chatterton Vice President Regulatory Affairs/Technical Ansell Perry 1875 Harsh Avenue, S.E. Massillon, Ohio 44646-7199
K974783 Re : Encore Mark IV Powder Free Latex Surgical Trade Name: Gloves, Polymer Coated Requlatory Class: ने Product Code: KGO Dated: December 18, 1997 December 22, 1997 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 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 Requlations, Title 21, Parts 800 to 895. A ------substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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 Product Radiation Control provisions, or other Federal laws or regulations.
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 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/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
3.0 Indications for Use Statement:
..............................................................................................................................................................................
INDICATIONS FOR USE
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Surgeons Glove, latex polymer coated, powder free Device Name:
Indications For Use:
A device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Qia S. Lin
(Division Sign-Off) Division of Dental, Inf and General Hospit : : (k) Number
Prescription Use Per 21 CFR 801.109 OR
Over-The-Counter
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