(198 days)
A device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The device has been tested for use with chemotherapy drugs.
The Encore Acclaim Sterile Powder-Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim <50µg/dm2 per Glove of Extractable Protein, is a disposable device made of natural latex rubber that is intended to be worn by operating room personnel to protect a surgical wound from contamination, and is tested for use with chemotherapy drugs.
The document is a 510(k) summary for the Encore® Acclaim® Sterile Powder-Free Latex Surgical Gloves. It describes the device, its intended use, and the studies conducted to demonstrate its safety and effectiveness.
Here’s a breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Standard (Acceptance Criteria) | Device Performance |
|---|---|---|
| Dimensions | ASTM D3577-09e1 | Meets |
| Physical Properties | ASTM D3577-09e1 | Meets |
| Freedom from Holes | ASTM D3577-09e1, ASTM D 5151-06 | Meets |
| Powder-Free | ASTM D 6124-06 (≤ 2 mg per glove) | ≤ 2 mg per glove |
| Protein Content | ASTM D3577-09e1, ASTM D 5712 (Maximum 50 µg/dm²) | Maximum 50 µg/dm² |
| Biocompatibility: Dermal Sensitization | (No specific standard number mentioned, but implies passing criteria) | Passes |
| Biocompatibility: Primary Skin Irritation Study | (No specific standard number mentioned, but implies passing criteria) | Passes |
| Chemotherapy Drug Permeation | ASTM D6978-05 (Breakthrough detection time in minutes) | Reported Time (minutes) |
| Vincristine Sulfate (1.0mg/mL) | (Implied >0, but no explicit minimum) | >240 |
| Carmustine (BiCNU) (3.3mg/mL) | (Implied >0, but no explicit minimum) | 1.5 |
| Cyclophosphamide (Cytoxan) (20.0mg/mL) | (Implied >0, but no explicit minimum) | >240 |
| Doxorubicin Hydrochloride (2.0mg/mL) | (Implied >0, but no explicit minimum) | >240 |
| 5-Fluorouracil (50.0mg/mL) | (Implied >0, but no explicit minimum) | >240 |
| Methotrexate (25.0mg/mL) | (Implied >0, but no explicit minimum) | >240 |
| Etoposide (Toposar) (20.0mg/mL) | (Implied >0, but no explicit minimum) | >240 |
| Paclitaxel (Taxol) (6.0mg/mL) | (Implied >0, but no explicit minimum) | >240 |
| ThioTEPA (10.0mg/mL) | (Implied >0, but no explicit minimum) | 15.26 |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each test (e.g., dimensions, physical properties, freedom from holes, powder-free, protein content, biocompatibility, or chemotherapy drug permeation). It mentions that the device was "tested against the ASTM standards," which would implicitly define sample size requirements within those standards, but the specific numbers are not provided in this summary.
The data provenance is from non-clinical performance data conducted by Ansell Healthcare Products LLC. There is no information provided about the country of origin of the data or whether it was retrospective or prospective, though performance testing is typically prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information is generally not applicable to the performance testing of medical devices like surgical gloves. The "ground truth" for these tests is established by adhering to widely accepted, standardized testing protocols (e.g., ASTM standards) rather than expert consensus on individual cases. The results are objective measurements.
4. Adjudication method for the test set
Not applicable. The tests performed are objective, measurable outcomes based on ASTM standards. There is no subjective interpretation requiring an adjudication method.
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 device for personal protection, not an AI-assisted diagnostic or interpretive tool. Therefore, MRMC studies and AI improvement effect sizes are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for demonstrating device performance consists of established, objective measurements specified by recognized industry standards (ASTM standards). For example, the ground truth for protein content is "Maximum 50 µg/dm²" as specified in ASTM D3577-09e1 and ASTM D5712. For chemotherapy drug permeation, the ground truth is the measured breakthrough time according to ASTM D6978-05.
8. The sample size for the training set
Not applicable. This device is a physical product, not a machine learning model. Therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set, this question is not relevant.
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KI03714
Ansell
JUL - 7 2011
1635 Industrial Road · Dothan, AL-36303-Tel: (334) 615-2563 Fax: (334) 615-2574
| 510(k) SUMMARY | |
|---|---|
| 1.0 | Submitter: Ansell Healthcare Products LLC1635 Industrial RoadDothan, AL 36303 |
| 2.0 | Contact Information: Cynthia A. Ingram, Regulatory Affairs Manager, AmericasTelephone: 334-615-2563 Fax: 334-615-2573 |
| 3.0 | Name of Device: |
| Trade Name: Encore® Acclaim® Sterile Powder-Free Latex SurgicalGloves, Tested for Use with Chemotherapy Drugs with aProtein Content Label Claim <50µg/dm² per Glove of Extractable Protein | |
| Common Name: Surgeon's Gloves | |
| Classification Name: Surgeon's Gloves | |
| 4.0 | Legally Marketed Devices to Which Equivalence is being Claimed: |
| Device Name: | Encore Mark IV Powder-Free Surgical Gloves |
|---|---|
| 510(k) Number: | K983489 |
| Device Name: | Duraprene Sterile Synthetic Powder-Free SurgicalGloves with Tested for use with ChemotherapyDrugs Labeling Claim |
| 510(k) Number: | K013302 |
- 5.0 Identification of the Device: Encore® Acclaim® Sterile Powder-Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim <50µg/dm² per Glove of Extractable Protein.
- 6.0 Description of the Device:
The Encore Acclaim Sterile Powder-Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim <50µg/dm2 per Glove of Extractable Protein, is a disposable device made of natural latex rubber that is intended to be worn by operating room personnel to protect a surgical wound from contamination, and is tested for use with chemotherapy drugs.
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7.0 Intended Use of the Device:
A device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The device has been tested for use with ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ chemotherapy drugs.
Chemotherapy Drug Permeation Chemotionals.crupy Drug Formediation
(average breakthrough detection time in minutes) (ASTM D6978-05)
| Vincristine Sulfate (1.0mg/mL) | >240 |
|---|---|
| Carmustine (BiCNU)(3.3mg/mL) | 1.5 |
| Cyclophosphamide (Cytoxan)(20.0mg/mL) | >240 |
| Doxorubicin Hydrochloride (2.0mg/mL) | >240 |
| 5-Fluorouracil (50.0mg/mL) | >240 |
| Methotrexate (25.0mg/mL) | >240 |
| Etoposide (Toposar)(20.0mg/mL) | >240 |
| Paclitaxel (Toxol)(6.0mg/mL) | >240 |
| ThioTEPA (10.0mg/mL) | 15.26 |
Please note that Carmustine and ThioTEPA have extremely low permeation times of 1.5 and 15.26 minutes respectively.
- Summary of Technological Characteristics of the Device: 8.0
Encore Acclaim Sterile Powder-Free Latex Surgical Gloves , Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim <50μg/dm2 per Glove of Extractable Protein have the following technological characteristics compared to ASTM or equivalent standards:
| Characteristics | Standard | Device Performance |
|---|---|---|
| Dimensions | ASTM D3577-09e1 | Meets |
| Physical Properties | ASTM D3577-09e1 | Meets |
| Freedom fromHoles | ASTM D3577-09e1ASTM D 5151-06 | Meets |
| Powder-Free | ASTM D 6124-06 | ≤ 2 mg per glove |
| Protein Content | ASTM D3577-09e1ASTM D 5712 | Maximum 50 μg/dm2 |
| Biocompatibility | Dermal SensitizationPrimary Skin Irritation Study | PassesPasses |
- Substantial Equivalence Based on Assessment of Non-Clinical Performance Data: 9.0 The subject device is substantially equivalent to the predicate devices based on an assessment of the non-clinical performance data.
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- Substantial Equivalence Based on an Assessment of Clinical Performance Data: 10.0 A clinical study was not conducted on the subject or predicate devices. ー・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
- 11.0 Conclusion:
The Encore Acclaim Sterile Powder-Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim <50µg/dm² per Glove of Extractable Protein is as safe and effective as the predicate devices. The subject device has been tested against the ASTM standards listed above and met the requirements of those standards.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Cynthia A. Ingram Regulatory Affairs Manager. Americas Ansell Healthcare Products. LLC 1635 Industrial Road Dothan, Alabama 36303
JUL - 7 2011
Re: K103714
Trade/Device Name: Encore Acclaim Sterile Powder-Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim >50µg/dm² Per Glove of Extractable Protein Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO. LZC Dated: June 16. 2011 Received: June 17, 2011
Dear Ms. Ingram:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above 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 Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2- Ms. Ingram
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803): good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm l 1 5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Anthony D, ant
Anthony D. Watson, B.S., M.S., M.B.A. 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: 3.0
INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
Encore Acclaim Sterile Powder-Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim <50µg/dm² per Glove of Extractable Protein
Indications For Use:
A device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The device has been tested for use with chemotherapy drugs.
Chemotherapy Drug Permeation Chemoticlerapy Drag Formedion time in minutes) (ASTM D6978-05)
| Vincristine Sulfate (1.0mg/mL) | >240 |
|---|---|
| Carmustine (BiCNU)(3.3mg/mL) | 1.5 |
| Cyclophosphamide (Cytoxan)(20.0mg/mL) | >240 |
| Doxorubicin Hydrochloride (2.0mg/mL) | >240 |
| 5-Fluorouracil (50.0mg/mL) | >240 |
| Methotrexate (25.0mg/mL) | >240 |
| Etoposide (Toposar)(20.0mg/mL) | >240 |
| Paclitaxel (Taxol)(6.0mg/mL) | >240 |
| ThioTEPA (10.0mg/mL) | 15.26 |
Please note that Carmustine and ThioTEPA have extremely low permeation times of 1.5 and 15.26 minutes respectively.
AND/OR Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use X (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)
Rophie Rangsukni, PhD.
7/16/2011
ision Sion-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K103714
§ 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).