(30 days)
Not Found
Not Found
No
The device is a surgical glove and the description focuses on material properties and performance standards, with no mention of AI or ML.
No
The device is a surgical glove intended for protection and handling chemotherapy drugs, not for treating a disease or condition.
No
The device is a surgical glove intended for protection, not for diagnosing a condition or disease.
No
The device is described as surgical gloves made of synthetic rubber, which are physical hardware components, 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 in vitro (outside the body) on specimens like blood, urine, or tissue.
- Device Description: The device is described as surgical gloves, which are a physical barrier.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on meeting glove performance standards (ASTM) and FDA hole requirements, which are related to the physical integrity and barrier function of the gloves, not diagnostic accuracy.
IVD devices are specifically designed to perform tests on specimens from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / 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.
Product codes
KGO
Device Description
Derma Prene® Ultra Powder-Free Polychloroprene 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.
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 [8] 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® Ultra Powder-Free Polychloroprene Synthetic [10] 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)
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
- 510(k) SUMMARY [ 1 ] Derma Prene® Ultra Powder-Free Polychloroprene Synthetic Surgical Gloves (Chemotherapy Use)
- [2] Ansell Healthcare Products LI.C. 1635 Industrial Road Dothan, AL 36303
Contact: Lon D. Mcllvain. Vice President Regulatory Affairs (334) 615-2562 Telephone: (334) 615-2568 Fax:
December 17, 2004
| [3] Trade Name: | Derma Prene® Ultra Powder-Free Polychloroprene Synthetic Surgical Gloves (Chemotherapy Use) |
|---|---|
| Common Name: | Surgical Gloves |
| Classification Name: | Surgeon's Glove |
- 141 Derma Prene® Ultra Powder-Free Polychloroprene Synthetic Surgical Gloves (Chemotherapy Use) meet all of the requirements of ASTM D 3577, Type 2.
- Derma Prene® Ultra Powder-Free Polychloroprene Synthetic Surgical Gloves ાં રા (Chemotherapy Use) meet all of the current specifications of ASTM D 3577, Type 2.
- Derma Prene® Ultra Powder-Free Polychloroprene Synthetic Surgical Gloves [6] (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.
- [7] Derma Prene® Ultra Powder-Free Polychloroprene 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 ASTM D 6124 |
| Powder content ≤ 2 mg per glove | |
| Biocompatibility | |
| Primary Skin Irritation in Rabbits | |
| Guinea Pig Sensitization | |
| Cytotoxicity Study using | |
| the End-Point Titration Method | Passes |
| Passes | |
| Non-Toxic at 24 hours |
1
- The performance test data of the non-clinical tests are the same as mentioned [8] immediately above.
- Clinical data is not needed for medical gloves or for most devices cleared by the ાં તે તે 510(k) process.
- It is concluded that Derma Prene® Ultra Powder-Free Polychloroprene Synthetic [10] 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.
- 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 text is stacked on top of each other, with "Public Health" on the top line and "Service" on the bottom line. The words are clearly legible and the image is simple and straightforward.
Image /page/2/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized design of three wavy lines.
JAN 1 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Lon D. Mcllvain Vice President Regulatory Affairs Ansell Healthcare Products LLC 1635 Industrial Road Dothan, Alabama 36303
Re: K043508
Ro43306
Trade/Device Name: Derma Prene® Ultra Powder-Free Green Polychloroprene Synthetic Surgical Gloves (Chemotherapy Use) Regulation Number: 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: December 17, 2004 Received: December 20, 2004
Dear Mr. Mcilvain:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave to rowed your 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 mendments, or to devices that have been reclassified in accordance with the provisions of / Including, or to ac read Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls promots or a 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 (1 MI), it may a subject of Federal Regulations, Title 21, Parts 800 to 898. In your device earner publish further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. Mcilvain
Please be advised that FDA's issuance of a substantial equivalence determination does not Please oe advised that 1 DT is issualites or that your device complies with other requirements Incall that I DA has made a decembers and regulations administered by other Federal agencies. of the Act of ally I edelar states and squirements, including, but not limited to: registration You must comply with an the Piece See Books (21 CFR Part 801); good manufacturing practice and listing (21 CF R Furt 607), labeling (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality systems (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) I mis letter will anow yourse begin finding of substantial equivalence of your device to a premits in the month - The PDF missis 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), If you desire specific at not to: Journer at (301) 594-0115. 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 may obtain 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,
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 Statement
| 510(k) Number (if known) | K043508 |
|---|---|
| Device Name | Derma Prene® Ultra Powder-Free Green Polychloroprene Synthetic Surgical Gloves (Chemotherapy Use) |
| 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. |
Prescription Use (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Sutte M. Ohaio O m.D.
(Division Sign Off) Oivision of Anesthesiology, General Hospital, Intection Control, Dental Devices
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KO43508 510(k) Number: _______________________________________________________________________________________________________________________________________________________________
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