(86 days)
Not Found
Not Found
No
The summary describes sterile surgical gloves made of neoprene and focuses on their physical properties and barrier performance, with no mention of AI or ML.
No.
The gloves are designed to protect a surgical wound from contamination and are worn by operating room personnel, not to treat a condition or disease in a patient.
No
This device, Duraprene Sterile Synthetic Surgical Gloves, is a medical glove intended for protecting surgical wounds from contamination and for use in sterile environments, not for diagnosing diseases or conditions.
No
The device is described as physical gloves made of neoprene, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that these gloves are for use in sterile environments during surgical procedures to protect a surgical wound from contamination. This is a physical barrier function, not a diagnostic test performed on a sample from the human body.
- Device Description: The description details the material and sterility of the gloves, which are physical characteristics, not components of a diagnostic assay.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample (blood, urine, tissue, etc.)
- Detecting or measuring a substance in a sample
- Providing information for diagnosis, monitoring, or screening of a disease or condition
Therefore, the Duraprene Sterile Synthetic Surgical Gloves are a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Powder-Free Duraprene™ Sterile Synthetic Surgical Gloves are intended for use in sterile environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive surgical procedures and non-invasive medical procedures requiring sterility. They are intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloves are constructed from synthetic materials. They are intended to provide an alternative to wearers and patients sensitive to natural rubber.
These gloves are intended for use in sterile environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive surgical procedures as well as non-invasive activities requiring sterility. They are designed to be worn by operating room personnel to protect a surgical wound from contamination.
Product codes
KGO
Device Description
The Duraprene Sterile Synthetic Surgical Gloves are formulated using neoprene and offered sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operating room personnel, hospitals and other healthcare facilities
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
| Test | Result |
|---|---|
| Intracutaneous Reactivity | Glove does not elicit irritation following intradermal injection of extracts. |
| Kligman Maximization Sensitization | Glove does not display potential to produce skin sensitization. |
| USP Mouse Systemic Test | No systemic response was observed. |
| Ultimate Elongation & Tensile Strength | Glove meets or exceeds requirements for rubber surgical gloves per ASTM D3577-91. |
| Barrier Defects | Glove meets or exceeds requirements per 21 CFR §800.20, AQL = 2.5 and ASTM D3577-91, AQL=1.5. |
| Data/Test Method | Gloves meet powder level requirements for "Powder Free" designation using the vacuum filtration method plus a negative iodine test. Results generated values below the 2mg/glove cornstarch level including |
Key Metrics
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Predicate Device(s)
Duraprene™ Sterile Synthetic Surgical Gloves
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
Image /page/0/Picture/3 description: The image shows the word "Allegiance" in a bold, stylized font. To the left of the word is a symbol that resembles a plus sign made up of small squares. The word is written in all capital letters and appears to be the logo for a company or organization.
JUL - 9 1997
510(k) SUMMARY K971381
| Manufacturer: | Allegiance Healthcare Corporation
Route 35 West
Eaton, Ohio 45320 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: | Maryalice Smith
1500 Waukegan Road, Bldg. K
McGaw Park, IL 60085 |
| Telephone: | (847) 785-3322 |
| Date Summary Prepared: | March, 1997 |
| Product Trade Name: | Powder-Free Duraprene™ Sterile Synthetic Surgical Gloves |
| Common Name: | Surgical Glove |
| Classification: | Glove, Surgical |
| Predicate Devices: | Duraprene™ Sterile Synthetic Surgical Gloves |
| Description: | The Duraprene Sterile Synthetic Surgical Gloves are formulated using
neoprene and offered sterile. |
| Intended Use: | Powder-Free Duraprene™ Sterile Synthetic Surgical Gloves are
intended for use in sterile environments within hospitals and
other healthcare facilities. The gloves are appropriate for
use during invasive surgical procedures and non-invasive medical
procedures requiring sterility. They are intended to be worn by
operating room personnel to protect a surgical wound from
contamination. These gloves are constructed from synthetic
materials. They are intended to provide an alternative to wearers and
patients sensitive to natural rubber. |
1
Substantial Equivalence:
The Powder-Free Duraprene™ Sterile Synthetic Surgical Gloves are substantially equivalent to powdered DurapreneTM Surgical Gloves in that they provide the following characteristics:
- intended use
- size, configuration, packaging
- made of synthetic materials
- tensile strength and thickness profiles
Summary of Testing:
| Test | Result |
|---|---|
| Intracutaneous Reactivity | Glove does not elicit irritation following |
| intradermal injection of extracts. | |
| Kligman Maximization | |
| Sensitization | Glove does not display |
| potential to produce skin sensitization. | |
| USP Mouse Systemic Test | No systemic response was observed. |
| Ultimate Elongation | |
| & Tensile Strength | Glove meets or exceeds |
| requirements for rubber | |
| surgical gloves per | |
| ASTM D3577-91. | |
| Barrier Defects | Glove meets or exceeds |
| requirements per 21 CFR | |
| §800.20, AQL = 2.5 and | |
| ASTM D3577-91, AQL=1.5. | |
| Data/Test Method | Gloves meet powder level |
| requirements for "Powder Free" | |
| designation using the vacuum filtration | |
| method plus a negative iodine test. | |
| Results generated values below the | |
| 2mg/glove cornstarch level including |
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird with three human profiles incorporated into its design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Maryalice Smith 'Requlatory Affairs Manager Allegiance Healthcare Corporation 1500 Waukegan Road, Bldg. K McGaw Park, Illinois 60085
K971381 Re : Powder-Free Duraprene Sterile Synthetic Trade Name: Surqical Gloves Requlatory Class: I Product Code: KGO JUL - 9 1997 Dated: April 10, 1997 Received: April 14, 1997
Dear Ms. Smith:
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 aqainst 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 Regulation (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 requlation may result in regulatory action. In addition, FDA may publish further announcements 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 - Ms. Smith
through 542 of the Act for devices under the Electronic chrough 542 or the not of 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 acberroom in postantial equivalence of your device to a legally marketed predicate device results in a classification for your markets production 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 compriation 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,
K. Celatnids
Timo Why Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/1 description: The image shows the word "Allegiance" in a bold, sans-serif font. To the left of the word is a symbol that looks like a plus sign made up of small squares. The word is in black and the background is white.
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085 917.473.1500
Page 1 of 1
| Applicant: | Allegiance Healthcare Corporation |
|---|---|
| 510(k) Number (if known): | K971381 |
| Device Name: | Powder-Free Duraprene TM Sterile Synthetic Surgical Gloves |
| Indications For Use: | These gloves are intended for use in sterile environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive surgical procedures as well as non-invasive activities requiring sterility. They are designed 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
| (Division Sign-Off) Division of Dental, Infection Control. and General Hospital Devices | Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|---|
| 510(k) Number | K971381 | |
| Prescription Use (Per 21 CFR 801.109) | or | Over-The Counter Use |
| ✓ |