(71 days)
The provided text does not contain K/DEN numbers for the predicate devices.
Not Found
No
The document describes standard surgical gloves and their performance characteristics, with no mention of AI or ML technology.
No
The device, surgical gloves, is intended to protect healthcare personnel and prevent contamination, not to treat or diagnose a medical condition in a patient.
No
The provided text describes surgical gloves intended to protect surgical wounds from contamination and does not mention any function related to diagnosing diseases or conditions.
No
The device is described as physical gloves made of synthetic rubber latex, intended for use in surgical procedures. The description and performance studies focus on material properties and barrier function, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the gloves are for protecting a surgical wound from contamination and for use during medical procedures. This is a barrier function for the user and the patient, not a diagnostic test performed on a sample from the human body.
- Device Description: The description details the material and form of the gloves, which are physical barriers.
- 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.
- Performance Studies: The performance studies focus on the physical properties of the gloves (irritation, sensitization, strength, barrier integrity, powder level), which are relevant to their function as a protective barrier, not as a diagnostic tool.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Powder-Free Sterile Synthetic Surgical Gloves are intended for use in environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive 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 intended to be worn by operating room personnel to protect a surgical wound from contamination in environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive as well as non-invasive medical procedures requiring sterility.
Product codes
KGO
Device Description
Powder-Free Sterile Synthetic Surgical gloves are formulated using Synthetic Rubber Latex. These are offered powder-free and sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
operating room personnel
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
Substantial Equivalence: Powder-Free Surgical Gloves are substantially equivalent to Duraprene Powder-Free Sterile Synthetic Surgical Gloves in that they provide the following characteristics: - same intended use, - same sizes, product features, packaging, - both made of Synthetic Rubber Latex using similar manufacturing process; Summary of Testing: Intracutaneous Reactivity: Gloves show no irritation. Guinea Pig Maximization: Gloves do not display any potential for sensitization. Ultimate Elongation & Tensile Strength: Gloves exceed requirements for rubber surgical gloves per ASTM D3577-00. Barrier Defects: Gloves exceed requirements per 21 CFR §800.20 and ASTM D3577-00, AQL = 1.5. Powder Level: Gloves meet powder level requirements for "Powder Free" designation using ASTM Standard D6124-97-Standard test method for residual powder on medical gloves. Results generated values below 2 mg of residual powder per glove.
Key Metrics
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Predicate Device(s)
Duraprene Powder-Free Sterile Synthetic Surgical Gloves
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
AUG 1 4 2001
XIII. SUMMARY OF SAFETY AND EFFECTIVENESS
KO/1721
Allegiance
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS POWDER-FREE STERILE SYNTHETIC SURGICAL GLOVES
| Regulatory Affairs Contact: Erica Sethi | Allegiance Healthcare Corporation
1500 Waukegan Road, MP-WM
McGaw Park, IL 60085 |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone: | (847) 785-3337 |
| Date Summary Prepared: | 5/25/01 |
| Product Trade Name: | Esteem Sterile Polyisoprene Surgical gloves |
| Common Name: | Surgical Glove |
| Classification: | Glove, Surgeon's |
| Predicate Devices: | Duraprene Powder-Free Sterile Synthetic Surgical Gloves |
| Description: | Powder-Free Sterile Synthetic Surgical gloves are formulated using
Synthetic Rubber Latex. These are offered powder-free and sterile. |
| Intended Use: | Powder-Free Sterile Synthetic Surgical Gloves are
intended for use in environments within hospitals and other
healthcare facilities. The gloves are appropriate for use during
invasive and non-invasive medical procedures requiring sterility.
They are intended to be worn by operating room personnel to
protect a surgical wound from contamination. |
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Koi ICI
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Substantial Equivalence:
Powder-Free Surgical Gloves are substantially equivalent to Duraprene Powder-Free Sterile Synthetic Surgical Gloves in that they provide the following characteristics:
- same intended use
Gloves show no irritation.
- same sizes, product features, packaging
- both made of Synthetic Rubber Latex using similar manufacturing process
Summary of Testing:
Test
Result
Intracutaneous Reactivity
Guinea Pig Maximization
Ultimate Elongation & Tensile Strength
Barrier Defects
Data/Test Method
Gloves do not display any potential for sensitization.
Gloves exceed requirements for rubber surgical gloves per ASTM D3577-00.
Gloves exceed requirements per 21 CFR $800.20 and ASTM D3577-00, AQL = 1.5.
Gloves meet powder level requirements for "Powder Free" designation using ASTM Standard D6124-97-Standard test method for residual powder on medical gloves. Results generated values below 2 mg of residual powder per glove.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Image /page/2/Picture/10 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 4 2001
Ms. Erica Sethi Manager of Regulatory Affairs Allegiance Healthcare Corporation 1500 Waukegan Road 60085 McGaw Park, Illinois
K011721 Re : Powder-Free Sterile Synthetic Trade/Device Name: Polyisoprene Surgical Gloves Regulation Number: 878.4460 Regulatory Class: I Product Code: KGO Dated: May 4, 2001 Received: June 4, 2001
Dear Ms. Sethi:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the marree is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate abe beaut in on erstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to che chat have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). provisions of the roading the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual provistration, 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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
3
Page 2 - Ms. Sethi
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 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) 594-4692. 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 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/dsma/dsmamain.html".
Sincerely yours,
Patricia Cuesnitoffor
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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fillegarra
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: 847.785.2460
Page 1 of 1
| Applicant: | Allegiance Healthcare Corporation |
|---|---|
| 510(k) Number: | K011721 |
| Device Name: | Powder-Free Sterile Synthetic Surgical Gloves (POLYISOPRENE) |
| Indications For Use: | These gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination in environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive as well as non-invasive medical procedures requiring sterility. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OL
Over-The Counter Use _
Qiu Si Lin
(Division Sign-Off) (Division of Dental, Infection Control,
Division of Dental, Infection Control, Division of Dentall Device 510(k) Number -6