(80 days)
The examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation of Chemotherapy Drugs.
Textured, Blue, Latex Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs With Protein Labeling Claim (50µg/dm² Or Less Of Water Soluble Protein).
This document describes the acceptance criteria and performance of "Textured, Blue, Latex Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs With Protein Labeling Claim (50µg/dm² Or Less Of Water Soluble Protein)".
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard / Acceptance Criteria | Device Performance |
|---|---|---|
| Physical Properties | ||
| Dimension | ASTM Standard D3578-05 | Meets |
| Physical Properties | ASTM Standard D3578-05 | Meets |
| Freedom from Pinholes | 21 CFR 800.20; ASTM D5151-06 | Meets |
| Powder Residual | ASTM Standard D6124-06 (Maximum of 2mg/glove) | Meets (results generated values below 2 mg of residual powder) |
| Protein Level | ASTM Standard D5712-10 (Maximum of 50 mcg/dm² of water soluble protein) | Meets (results generated values below 50 mcg/mg of protein) |
| Biocompatibility | ||
| Biocompatibility | Biological Evaluation of Medical Devices part 1: Evaluation and Testing (ISO 10993-1:2009) | Meets |
| Primary Skin Irritation | Primary Skin Irritation in rabbits (ISO 10993-10:2010) | Gloves are non-irritating |
| Dermal Sensitization | Dermal Sensitization in the guinea pig (ISO 10993-10:2010) | Gloves do not display any potential for sensitization |
| Chemotherapy Permeation | ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation of Chemotherapy Drugs (Minimum Breakthrough Detection Time) | |
| Carmustine (BCNU) (3.3 mg/mL) | Minimum breakthrough detection time is specified by the standard for each drug. The device must meet or exceed this time. For specific claims, the measured time becomes the claim. | Average Breakthrough Detection Time: 15.4 minutes (Note: "extremely low permeation time of less than 30 minutes" is stated, indicating that 15.4 mins is the reported time which must be acceptable based on the standard and drug's known permeability) |
| Cisplatin (1.0 mg/mL) | No breakthrough up to 240 min (>240 minutes) | |
| Cyclophosphamide (Cytoxan) (20.0 g/mL) | No breakthrough up to 240 min (>240 minutes) | |
| Dacarbazine (DTIC) (10.0 mg/mL) | No breakthrough up to 240 min (>240 minutes) | |
| Doxorubicin Hydrochloride (2.0 mg/mL) | No breakthrough up to 240 min (>240 minutes) | |
| Etoposide (20.0 mg/mL) | No breakthrough up to 240 min (>240 minutes) | |
| Fluorouracil (Adrucil) (50.0 mg/mL) | No breakthrough up to 240 min (>240 minutes) | |
| Methotrexate (25.0 mg/mL) | No breakthrough up to 240 min (>240 minutes) | |
| Mitomycin C (0.5mg/mL) | No breakthrough up to 240 min (>240 minutes) | |
| Paclitaxel (Taxol) (6.0mg/mL) | No breakthrough up to 240 min (>240 minutes) | |
| Thiotepa (10.0 mg/mL) | Average Breakthrough Detection Time: 1.6 minutes (Note: "extremely low permeation time of less than 30 minutes" is stated, indicating that 1.6 mins is the reported time which must be acceptable based on the standard and drug's known permeability) | |
| Vincristine Sulfate (1.0 mg/mL) | No breakthrough up to 240 min (>240 minutes) |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not explicitly state the specific sample sizes used for each individual test (e.g., number of gloves tested for pinholes, physical properties, or chemotherapy permeation). However, it implicitly suggests that testing was conducted in accordance with the cited ASTM and ISO standards, which would define appropriate sample sizes for each evaluation.
The data provenance is not specified in terms of country of origin. The studies appear to be prospective laboratory tests conducted according to established international and US standards (ASTM, ISO, 21 CFR).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
For the type of device and tests conducted (physical, chemical, and biocompatibility), the "ground truth" is established by adherence to specified, objective, and standardized testing methodologies. This typically involves trained laboratory technicians and/or engineers performing the tests, rather than a panel of "experts" as seen in clinical diagnostic studies. The qualifications would be expertise in conducting the specific ASTM and ISO standard tests. The document does not specify the number or specific qualifications of these individuals.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 typically apply to studies where human interpretation of data (e.g., medical images) is involved and discrepancies need to be resolved. For objective laboratory tests like those performed on gloves, the results are quantitative and directly compared against the pass/fail criteria of the standard.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical data, often with and without AI assistance, to assess the impact of AI on diagnostic performance. This device is a medical glove, and its performance is evaluated through standardized physical, chemical, and biocompatibility tests, not human interpretation of medical cases.
6. If a Standalone Study Was Done
Yes, the studies described are standalone (algorithm/device only) in the sense that the performance of the glove itself was evaluated directly against the specified standards, without involving human users "in the loop" for the primary performance evaluations described. The performance metrics are objective measurements (e.g., tensile strength, pinhole count, breakthrough time, protein levels).
7. The Type of Ground Truth Used
The ground truth used for these studies is based on:
- Established Standards and Regulatory Requirements: The performance is measured against the criteria defined by ASTM standards (D3578-05, D5151-06, D6124-06, D5712-10, D6978-05), ISO standards (10993-1:2009, 10993-10:2010), and U.S. FDA regulations (21 CFR 800.20).
- Objective Laboratory Measurements: Data is generated through physical, chemical, and biological testing protocols designed to yield quantitative and qualitative results that are then compared to the acceptance criteria specified in the standards.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product (medical glove), not an AI algorithm requiring a training set. The performance is assessed through direct testing of the manufactured product.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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Abbreviated 510(k) Premarket Notification Latex Powder Free Examination Gloves
510(k) SUMMARY
Section 5, 510(k) Summary Page 1 of 3
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K121926/.
| DATE: | February 17, 2010 | SEP 2 0 2012 | |
|---|---|---|---|
| OWNER: | McKesson Medical Surgical International70 Sir John Rogerson's QuayDublin 2, Ireland | ||
| OFFICIAL CORRESPONDENT: | Anthony L. GiaccioManager, Quality Systems and Regulatory AffairsTelephone: 815-385-0100Fax: 815-385-0114Email: Anthony.Giaccio@mckesson.com | ||
| DEVICE NAME: | Trade Name: | Textured, Blue, Latex Powder Free ExaminationGloves, Tested For Use With ChemotherapyDrugs With Protein Labeling Claim (50μg/dm2Or Less Of Water Soluble Protein) | |
| Common Name: | Patient Examination Gloves | ||
| Classification: | Patient Examination Gloves | ||
| Class: | Class I | ||
| Product Code: | LZC |
PREDICATE DEVICE(S):
| Predicate510(k) | Device Name | Indication | ClearanceDate | Company |
|---|---|---|---|---|
| K083409 | Latex Powder FreeExamination Gloves(Blue) Tested ForUse WithChemotherapy Drugs | The latex examination glove (Tested forUse with Chemotherapy Drugs) is adisposable device intended for medicaland dental purposes that is worn on theexaminer's hand to preventcontamination between patient andexaminer. | 29 Jul 2009 | WRP ASIAPACIFIC SDN,BHD |
DEVICE DESCRIPTION: Textured, Blue, Latex Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs With Protein Labeling Claim (50µg/dm² Or Less Of Water Soluble Protein).
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STATEMENT OF INTENDED USE:
The examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
i
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation of Chemotherapy Drugs:
Chemotherapy Drug Permeation (Breakthrough Detection Time in Minutes)
| Chemotherapy Drug | Average BreakthroughDetection Time (Min) |
|---|---|
| Carmustine (BCNU) (3.3 mg/mL) | 15.4 |
| Cisplatin (1.0 mg/mL) | No breakthrough up to 240 min |
| Cyclophosphamide (Cytoxan)(20.0 g/mL) | No breakthrough up to 240 min |
| Dacarbazine (DTIC) (10.0mg/mL) | No breakthrough up to 240 min |
| Doxorubicin Hydrochloride (2.0mg/mL) | No breakthrough up to 240 min |
| Etoposide (20.0 mg/mL) | No breakthrough up to 240 min |
| Fluorouracil (Adrucil) (50.0mg/mL) | No breakthrough up to 240 min |
| Methotrexate (25.0 mg/mL) | No breakthrough up to 240 min |
| Mitomycin C (0.5mg/mL) | No breakthrough up to 240 min |
| Paclitaxel (Taxol) (6.0mg/mL) | No breakthrough up to 240 min |
| Thiotepa (10.0 mg/mL) | 1.6 |
| Vincristine Sulfate (1.0 mg/mL) | No breakthrough up to 240 min |
The maximum testing time is 240 minutes. Please note that the following drugs, Carmustine and Thiotepa, have extremely low permeation time of less than 30 minutes.
The Latex Powder Free Examination Glove is substantially equivalent to the predicate device with regard to physical characteristics, design, product features, and intended use. Both gloves are made with latex using similar manufacturing processes. In addition, both gloves have been tested for use with chemotherapy drugs.
TECHNOLOGICAL CHARACTERISTICS:
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Abbreviated 510(k) Premarket Notification Latex Powder Free Examination Gloves
Section 5, 510(k) Summary Page 3 of 3
:
ASSESSMENT OF NONCLINICAL DATA:
| Characteristic | Standard | DevicePerformance |
|---|---|---|
| Dimension | ASTM Standard D3578-05 | Meets |
| Physical Properties | ASTM Standard D3578-05 | Meets |
| Freedom fromPinholes | 21 CFR 800.20; ASTM D5151-06 | Meets |
| Powder Residual | ASTM Standard D6124-06 | MeetsResults generatedvalues below 2mg ofresidual powder |
| Protein Level | ASTM Standard D5712-10 | MeetsResults generatedvalues below 50mcg/mg of protein |
| Biocompatibility | Biological Evaluation of MedicalDevices part 1: Evaluation andTesting (ISO 10993-1:2009) | Meets |
| Primary Skin Irritation in rabbits(ISO 10993-10:2010) | Gloves are non-irritating | |
| Dermal Sensitization in theguinea pig (ISO 10993-10:2010) | Gloves do not displayany potential forsensitization |
CONCLUSIONS:
The Latex Powder Free Examination Gloves meet the requirements of established standards ASTM D3578-05, ASTM D5712-10, ASTM D5151-06, ASTM D6124-06 ISO 10993-1:2009 and ISO 10993-10:2010.
Based on the comparison of intended use, design, materials and performance, the Latex Powder Free Examination Gloves Tested for Use With Chemotherapy Drugs are substantially equivalent to the predicate device.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 20 2012
Northstar Healthcare Holdings C/O Mr. Ned Devine Senior Staff Engineer Underwriters Laboratories. Incorporated 333 Pfingsten Road Northbrook, Illinois 60062
Re: K121926
Trade/Device Name: Textured, Blue, Latex Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs With Protein Labeling Claim (50 ug/dm2 Or Less Of Water Soluble Protein)
Regulation Number: 21 CFR 880.6250
Regulation Name: Patient Examination Gloves
Regulatory Class: Class I
Product Code: LZC
Dated: September 4, 2012
Received: September 5, 2012
Dear Mr. Devine:
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- Mr. Devine
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/ucm115809.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,
For Scott Robertson
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
510(k) Number (if known): K121926
Device Name: Textured, Blue, Latex Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs With Protein Labeling Claim (50ug/dm2 Or Less Of Water Soluble Protein).
Indications for Use: The examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation of Chemotherapy Drugs:
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time inMinutes |
|---|---|
| Carmustine (BCNU)(3.3 mg/mL) | 15.4 |
| Cisplatin (1.0 mg/mL) | >240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/mL) | >240 |
| Dacarbazine (DTIC) (10.0 mg/mL) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/mL) | >240 |
| Etoposide (20.0 mg/mL) | >240 |
| Fluorouracil (Adrucil) (50.0 mg/mL) | >240 |
| Methotrexate (25 mg/mL) | >240 |
| Mitomycin C (0.5mg/mL) | >240 |
| Paclitaxel (taxol) (6.0 mg/mL) | >240 |
| Thiotepa (10.0 mg/mL) | 1.6 |
| Vincristine Sulfate (1.0 mg/mL) | >240 |
The maximum testing time is 240 minutes. Please note that the following drugs, Carmustine (BCNU) and Thiotepa have extremely low permeation time of less than 30 minutes.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ion of Anestheslology, General Hospital Infection Control, Dental Devices
510(k) Number;
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination 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). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.