(30 days)
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.
Derma Prene® Ultra Powder-Free Polychloroprene Synthetic Surgical Gloves (Chemotherapy Use) meet all of the requirements of ASTM D 3577, Type 2.
The provided text pertains to the 510(k) premarket notification for Ansell's Derma Prene® Ultra Powder-Free Polychloroprene Synthetic Surgical Gloves (Chemotherapy Use). It describes the device's characteristics and its conformance to established standards rather than a study proving the device meets acceptance criteria in the context of a typical AI/software medical device.
Therefore, many of the requested categories (e.g., sample size for test/training sets, number/qualifications of experts, adjudication method, MRMC study, standalone performance) are not applicable to this type of device submission, as it's a conventional medical glove and not an AI-powered diagnostic or therapeutic device.
However, I can extract the relevant acceptance criteria and the "study" (which in this case refers to conformance testing against established standards) that proves the device meets these criteria.
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria | Standard | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D 3577 | Meets ASTM D 3577 |
| Physical Properties | ASTM D 3577, Type 2 | Meets ASTM D 3577, Type 2 |
| Freedom from Holes | ASTM D 3577 & ASTM D 5151 | Meets ASTM D 3577, Meets ASTM D 5151 |
| Powder-Free | ASTM D 6124 | Meets ASTM D 6124, Powder content ≤ 2 mg per glove |
| Biocompatibility: | Not explicitly stated standard | |
| - Primary Skin Irritation in Rabbits | Not explicitly stated standard | Passes |
| - Guinea Pig Sensitization | Not explicitly stated standard | Passes |
| - Cytotoxicity Study using End-Point Titration Method | Not explicitly stated standard | Non-Toxic at 24 hours |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. For physical and biocompatibility testing of medical gloves, samples are typically drawn from manufacturing lots according to the respective ASTM standards, but specific numbers are not provided in this summary.
- Data Provenance: The nature of the studies (e.g., irritation, sensitization, cytotoxicity) suggests laboratory-based testing. The country of origin for the data is not specified, but the applicant (Ansell Healthcare Products LLC) is based in the USA. The studies are prospective in the sense that they are performed specifically to demonstrate compliance for this device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. For medical gloves, "ground truth" is established by conformance to objective, standardized testing methods (e.g., ASTM standards) rather than expert consensus on diagnostic images or clinical outcomes. The tests are conducted in laboratories by trained personnel following validated protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or for establishing ground truth from expert readings, which is not relevant to the physical and biocompatibility testing of gloves described here. Conformance is determined by meeting pre-defined thresholds in laboratory tests.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is a medical glove, not an AI-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a medical glove, not an AI-powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Objective Test Results against Standards: The "ground truth" is defined by the objective measurements and observations obtained from standardized laboratory tests (e.g., tensile strength, elongation, presence of holes, powder content, skin irritation responses) which are then compared against the acceptance criteria specified in the relevant ASTM standards.
8. The sample size for the training set
- Not Applicable. No training set is involved as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
- Not Applicable. No training set is involved.
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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 3577Meets ASTM D 5151 |
| Powder-Free | Meets ASTM D 6124Powder content ≤ 2 mg per glove |
| BiocompatibilityPrimary Skin Irritation in RabbitsGuinea Pig SensitizationCytotoxicity Study usingthe End-Point Titration Method | PassesPassesNon-Toxic at 24 hours |
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- 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.
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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.
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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
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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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§ 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).