(199 days)
A 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.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
Chemotherapy Drug Permeation
The following chemicals have been tested with these gloves.
| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|---|---|---|
| Flourouracil (Adrucil) | 50.0mg/ml | > 240 |
| Etopside (Toposar) | 20.0mg/ml | > 240 |
| Cyclophosphamide (Cytoxan) | 20.0mg/ml | > 240 |
| *Carmustine (BCNU) | 3.3mg/ml | 15.0 |
| *Thiotepa | 10.0mg/ml | 2.0 |
| Paclitaxel (Taxol) | 6.0mg/ml | > 240 |
| Doxorubicin Hydrochloride (Adriamycin) | 2.0mg/ml | > 240 |
| Dacarbazine | 10.0mg/ml | > 240 |
| Cisplatin | 1.0mg/ml | > 240 |
| Ifosfamide | 50.0mg/ml | > 240 |
| Mitoxantrone | 2.0mg/ml | > 240 |
| Vincristine Sulfate | 1.0mg/ml | > 240 |
- Please note that the following drugs have extremely low permeation times: Carmustine (BCNU) : 15 minutes and Thiotepa : 2 minutes
Powder Free Blue Nitrile Patient Examination Glove, Non-Sterile meets all the requirements of ASTM standard D6319-10, D6978-05 and FDA 21 CFR 880.6250.
The powder free nitrile examination glove is manufactured from synthetic rubber latex. Inner surface of gloves undergo surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder on the qlove surface. The qlove is ambidextrous, i.e. can be worn on right hand or left hand. The physical properties of glove i.e. tensile strength meets ASTM standard D6319-10.
The provided document describes the acceptance criteria and performance of the "Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, Tested for use with Chemotherapy Drugs" to demonstrate substantial equivalence to a predicate device (Kimberly-Clark STERLING Nitrile Powder-Free Exam Gloves with a Chemotherapy Drug Use Claim, K081089).
Here's an analysis of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily defined by adherence to various ASTM standards and performance comparable to the predicate device. The reported device performance indicates compliance with these standards.
| Characteristic | Standard/Acceptance Criteria | Reported Device Performance (Current Device) | Predicate Device Performance |
|---|---|---|---|
| Physical Properties | ASTM D6319-10 | Meets | Meets |
| Dimensions | ASTM D6319-10 (Min 240mm length) | Min 240mm | Conforms to ASTM 6319-00a |
| Thickness - Finger | ASTM D6319-10 (0.07 - 0.10mm) | 0.07 - 0.10mm | 0.07 - 0.10mm |
| Thickness - Palm | Not explicitly stated as a separate standard, but implied by D6319-10 (0.07 – 0.09mm) | 0.07 – 0.09mm | 0.07 – 0.09mm |
| Thickness - Cuff | Not explicitly stated as a separate standard, but implied by D6319-10 (0.06 - 0.08mm) | 0.06 - 0.08mm | 0.06 - 0.08mm |
| Powder Free | ASTM D6124-06 (≤ 2 mg/glove) | Meets | Meets |
| Chemotherapy Drug Permeation | ASTM D6978-05 (Breakthrough Detection Time) | See specific drug results below | See specific drug results below |
| Flourouracil (Adrucil) | > 240 minutes | > 240 minutes | > 240 minutes |
| Etopside (Toposar) | > 240 minutes | > 240 minutes | > 240 minutes |
| Cyclophosphamide (Cytoxan) | > 240 minutes | > 240 minutes | > 240 minutes |
| *Carmustine (BCNU) | Not explicitly stated for current device, but predicate has no listed value. Current device reports 15 minutes. | 15.0 minutes | - |
| *Thiotepa | Not explicitly stated for current device, but predicate reports 54.2 minutes. Current device reports 2 minutes. | 2.0 minutes | 54.2 minutes |
| Paclitaxel (Taxol) | > 240 minutes | > 240 minutes | > 240 minutes |
| Doxorubicin Hydrochloride | > 240 minutes | > 240 minutes | > 240 minutes |
| Dacarbazine | > 240 minutes | > 240 minutes | > 240 minutes |
| Cisplatin | > 240 minutes | > 240 minutes | > 240 minutes |
| Ifosfamide | > 240 minutes | > 240 minutes | > 240 minutes |
| Mitoxantrone | > 240 minutes | > 240 minutes | > 240 minutes |
| Vincristine Sulfate | > 240 minutes | > 240 minutes | > 240 minutes |
| Biocompatibility | ISO 10993-10:2010(E) & Consumer Product Safety Commission, Title 16, Chapter II, Part 1500 (Primary Skin Irritation) | Passes (Not a primary skin irritant) | Passes |
| ISO 10993-10:2010(E) & Consumer Product Safety Commission, Title 16, Chapter II, Part 1500.3(c)(4) (Dermal Sensitization) | Passes (Not a contact sensitizer) | Passes | |
| Watertight | ASTM D5151-06 | Passes | Passes |
| Intended Use | Prevention of contamination between patient and examiner | Consistent with predicate | Consistent with predicate |
| Material | ASTM D6319-10 (Nitrile) | Nitrile | Nitrile |
| Color | Not a performance criterion, but a characteristic | Blue | Light Gray |
| Texture | Not a performance criterion, but a characteristic | Finger textured | Textured Fingertip |
| Size | Medical Glove Guidance Manual - Labeling (XS, S, M, L, XL) | Extra Small, Small, Medium, Large, Extra Large | Extra Small, Small, Medium, Large, Extra Large |
| Single Use | Medical Glove Guidance Manual - Labeling | Single use | Single use |
| Warning Statement | - | Required for drugs with low permeation times | Required for drugs with low permeation times |
Study Proving Device Meets Acceptance Criteria:
The studies cited are non-clinical performance tests conducted to demonstrate compliance with recognized industry standards. The submission explicitly states that "The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above (ASTM Requirements)." This implies specific tests were performed on the device to prove its compliance with each standard.
2. Sample size used for the test set and the data provenance
- The document does not specify the sample sizes used for the individual tests (e.g., how many gloves were tested for permeation, physical properties, or biocompatibility).
- The data provenance is non-clinical test data, performed by the manufacturer, WRP Asia Pacific Sdn Bhd, located in Malaysia. The tests are reported as being compliant with internationally recognized ASTM standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable to this type of submission. The "ground truth" for glove performance is established by adherence to standardized testing protocols (e.g., ASTM D6978-05 for chemotherapy drug permeation), not by expert consensus in a clinical setting.
- The document does not mention any medical experts' involvement in establishing test results or ground truth. The tests are laboratory-based.
4. Adjudication method for the test set
- Not applicable. Adjudication methods are typically associated with human interpretation of results, often in clinical or image-based studies. Here, the results are quantitative measurements against predefined standard thresholds.
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 submission for medical gloves, not an AI-powered diagnostic device. Therefore, no MRMC study or AI assistance is relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This involves physical product performance, not an algorithm.
7. The type of ground truth used
- The "ground truth" for the device's performance is compliance with established, quantitative, and standardized test methods (e.g., ASTM D6319-10 for physical characteristics, ASTM D6978-05 for chemotherapy drug permeation, ISO 10993-10 for biocompatibility, and ASTM D5151-06 for watertightness). The results are direct measurements against these standards.
8. The sample size for the training set
- Not applicable. This device is a physical product (gloves) and does not involve machine learning or AI, thus there is no "training set."
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for this device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 5, 2015
WRP Asia Pacific Sdn Bhd Ms. Sarala Devi Jayaraman Regulatory Affairs Manager Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi Sepang, Selangor Darul Ehsan Malaysia 43900
Re: K141982
Trade/Device Name: Dermagrip Powder Free Blue Nitrile Patient Examination Gloves Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZC, LZA Dated: December 23, 2014 Received: December 29, 2014
Dear Ms. Jayaraman:
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. Jayaraman
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K141982
Device Name
Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, Tested for use with Chemotherapy Drugs
Indications for Use (Describe)
A 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.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
Chemotherapy Drug Permeation
The following chemicals have been tested with these gloves.
| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|---|---|---|
| Flourouracil (Adrucil) | 50.0mg/ml | > 240 |
| Etopside (Toposar) | 20.0mg/ml | > 240 |
| Cyclophosphamide (Cytoxan) | 20.0mg/ml | > 240 |
| *Carmustine (BCNU) | 3.3mg/ml | 15.0 |
| *Thiotepa | 10.0mg/ml | 2.0 |
| Paclitaxel (Taxol) | 6.0mg/ml | > 240 |
| Doxorubicin Hydrochloride (Adriamycin) | 2.0mg/ml | > 240 |
| Dacarbazine | 10.0mg/ml | > 240 |
| Cisplatin | 1.0mg/ml | > 240 |
| Ifosfamide | 50.0mg/ml | > 240 |
| Mitoxantrone | 2.0mg/ml | > 240 |
| Vincristine Sulfate | 1.0mg/ml | > 240 |
- Please note that the following drugs have extremely low permeation times: Carmustine (BCNU) : 15 minutes and Thiotepa : 2 minutes
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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1.0 Submitter:
| Name: | Sarala Devi Jayaraman |
|---|---|
| Address: | WRP Asia Pacific Sdn BhdLot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900Sepang, Selangor Darul Ehsan, MALAYSIA |
| Phone No.: | +60 3 8706 1486 |
| Fax No.: | +60 3 8706 1485 |
Date of Summary Prepared: 4 February 2015
2.0 Name of the device:
Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, Tested for use with Chemotherapy Drugs Common Name: Exam Gloves Classification Name: Patient Examination Gloves Specialty (21 CFR 880.6250 product code LZC) Patient Examination Gloves (21 CFR 880.6250 product code LZA)
3.0 Identification of The Legally Marketed Devices that equivalency is claimed:
| Predicate | |
|---|---|
| Manufacturer | Kimberly-Clark Corporation |
| Device name | Kimberly-Clark STERLING NitrilePowder-Free Exam Gloves with aChemotherapy Drug Use Claim |
| 510(k) Number | K081089 |
| MDL | - |
| Regulatory Class | I |
| Product Code | LZC |
4.0 Description of The Device:
Powder Free Blue Nitrile Patient Examination Glove, Non-Sterile meets all the requirements of ASTM standard D6319-10, D6978-05 and FDA 21 CFR 880.6250.
The powder free nitrile examination glove is manufactured from synthetic rubber latex. Inner surface of gloves undergo surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder on the qlove surface. The qlove is ambidextrous, i.e. can be worn on right hand or left hand. The physical properties of glove i.e. tensile strength meets ASTM standard D6319-10.
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5.0 Intended Use of the Device:
A 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.
6.0 Summary of the Technological Characteristics of the Device:
The Powder Free Blue Nitrile Examination Gloves, Non-Sterile are summarized with the following technological characteristics compared to ASTM D6319 or equivalent standards as shown in Table 1
Chemotherapy claim is similar to Predicate, which has a glove thickness below 0.10mm and is shorter than 270mm but compliant with the ASTM standards.
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | |
|---|---|---|---|
| Predicate | Current | ||
| Manufacturer(s) | Kimberly-ClarkCorporation | WRP Asia Pacific SdnBhd | |
| 510(k) Number | K081089 | K141982 | |
| Dimensions | ASTM D6319-10 | Conforms to ASTM6319-00a | Min 240mm |
| Physical Properties | ASTM D6319-10 | Meets | Meets |
| Thickness - Finger | ASTM D6319-10 | 0.07 - 0.10mm | 0.07 - 0.10mm |
| - Palm | 0.07 – 0.09mm | 0.07 – 0.09mm | |
| - Cuff | 0.06 - 0.08mm | 0.06 - 0.08mm | |
| Powder Free | ASTM D6124-06(≤ 2 mg/glove) | Meets | Meets |
Table 1
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| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | |
|---|---|---|---|
| Predicate | Current | ||
| Chemotherapy DrugPermeation Test | ASTM D6978-05 | ||
| Test Chemotherapy Drug | Concentration | Minimum Breakthrough DetectionTime (min) | |
| Flourouracil (Adrucil) | 50.0mg/ml | > 240 | > 240 |
| Etopside (Toposar) | 20.0mg/ml | > 240 | > 240 |
| Cyclophosphamide (Cytoxan) | 20.0mg/ml | > 240 | > 240 |
| *Carmustine (BCNU) | 3.3mg/ml | - | 15.0 |
| *Thiotepa | 10.0mg/ml | 54.2 | 2.0 |
| Paclitaxel (Taxol) | 6.0mg/ml | > 240 | > 240 |
| Doxorubicin Hydrochloride(Adriamycin) | 2.0mg/ml | > 240 | > 240 |
| Dacarbazine | 10.0mg/ml | > 240 | > 240 |
| Cisplatin | 1.0mg/ml | > 240 | > 240 |
| Ifosfamide | 50.0mg/ml | > 240 | > 240 |
| Mitoxantrone | 2.0mg/ml | > 240 | > 240 |
| Vincristine Sulfate | 1.0mg/ml | > 240 | > 240 |
| Warning Statement | - | * WARNING:Please note thatthe followingdrugs haveextremely lowpermeation times:Carmustine(BCNU) : 15minutes andThiotepa : 2minutes. | |
| CHARACTERISTICSSTANDARDS | DEVICE PERFORMANCE | ||
| Predicate | Current | ||
| Biocompatibility | Primary Skin Irritation-ISO 10993-10:2010(E) &Consumer ProductSafety Commission,Tittle 16, Chapter II,Part 1500 | Passes | PassesNot a primary skin irritantunder the conditions ofthe study. |
| Dermal Sensitization -ISO 10993-10:2010(E) &Consumer ProductSafety Commission,Tittle 16, Chapter II,Part 1500.3(c)(4) | Passes | PassesNot a contact sensitizerunder the conditions ofthe study. | |
| Watertight (1000ml) | ASTM D5151-06 | Passes | Passes |
| Intended use | - | A patientexaminationglove is amedical deviceintended formedical purposesthat is worn onthe examiner'shand to preventcontaminationbetween patientand examiner. | A patient examinationglove is a disposabledevice intended formedical purposes thatis worn on theexaminer's hand orfinger to preventcontamination betweenpatient and examiner. |
| Material | ASTM D6319-10 | Nitrile | Nitrile |
| Color | - | Light Gray | Blue |
| Texture | - | Textured Fingertip | Finger textured |
| Size | Medical GloveGuidance Manual -Labeling | Extra SmallSmallMediumLargeExtra Large | Extra SmallSmallMediumLargeExtra Large |
| Single Use | Medical GloveGuidance Manual -Labeling | Single use | Single use |
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Substantial Equivalent Based on Assessment of Non-Clinical Performance 7.0 Data
The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above (ASTM Requirements).
The device and the predicate share the same intended use, same material, same specifications for thickness and length, similar permeation rates for chemotherapy drugs, similar labeling according to the glove guidance, and same compliance with standards for physical properties, powder free, biocompatibility and water tightness. Thus, the device is substantial equivalent to the predicate.
8.0 Substantial Equivalent Based on Assessment of Clinical Performance Data
Not applicable - Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
9.0 Conclusion
Based on intended uses, technological characteristics and non-clinical performance data, the subject device K141982 is substantially equivalent to the predicate device K081089.
§ 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.