(150 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:
Powder Free Blue Nitrile Patient Examination Glove, Non-Sterile the meets all requirements of ASTM standard D6319-10, D6978-05 and FDA 21 CFR 880.6250.
The powder free nitrile examination qlove is manufactured from synthetic rubber latex. Inner surface of gloves undergoes 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 glove surface. The glove is ambidextrous, i.e. can be worn on right hand or left hand. The physical properties of glove i.e. tensile strength meet ASTM standard D6319-10.
The provided text describes the acceptance criteria and performance of "Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-sterile, Tested For Use With Chemotherapy Drugs." This document is a 510(k) premarket notification to the FDA, asserting substantial equivalence to an existing predicate device (K141982).
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is compared to relevant ASTM standards. The table below summarizes the acceptance criteria and the device's reported performance:
| Characteristic | Standard/Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D6319-10 (Min 240mm length) | Min 240mm (Meets) |
| Physical Properties | ASTM D6319-10 | Meets |
| Thickness - Finger | ASTM D6319-10 (0.07 - 0.10mm) | 0.07 - 0.10mm (Meets) |
| Thickness - Palm | ASTM D6319-10 (0.07 - 0.09mm) | 0.07 - 0.09mm (Meets) |
| Thickness - Cuff | ASTM D6319-10 (0.06 - 0.08mm) | 0.06 - 0.08mm (Meets) |
| Powder Free | ASTM D6124-06 (≤ 2 mg/glove) | Meets |
| Chemotherapy Drug Permeation Test (ASTM D6978-05) | Minimum Breakthrough Detection Time (varies by drug) | |
| Flourouracil (Adrucil) | > 240 minutes | > 240 minutes (Meets) |
| Etopside (Toposar) | > 240 minutes | > 240 minutes (Meets) |
| Cyclophosphamide (Cytoxan) | > 240 minutes | > 240 minutes (Meets) |
| *Carmustine (BCNU) | 15.0 minutes | 15.0 minutes (Meets) |
| *Thiotepa | 2.0 minutes | 2.0 minutes (Meets) |
| Paclitaxel (Taxol) | > 240 minutes | > 240 minutes (Meets) |
| Doxorubicin Hydrochloride (Adriamycin) | > 240 minutes | > 240 minutes (Meets) |
| Dacarbazine | > 240 minutes | > 240 minutes (Meets) |
| Cisplatin | > 240 minutes | > 240 minutes (Meets) |
| Ifosfamide | > 240 minutes | > 240 minutes (Meets) |
| Mitoxantrone | > 240 minutes | > 240 minutes (Meets) |
| Vincristine Sulfate | > 240 minutes | > 240 minutes (Meets) |
| Methotrexate | > 240 minutes | > 240 minutes (Meets) |
| Mitomycin C | > 240 minutes | > 240 minutes (Meets) |
| Biocompatibility - Primary Skin Irritation | ISO 10993-10:2010(E) (Passes, Not a primary skin irritant) | Passes, Not a primary skin irritant under the conditions of the study. (Meets) |
| Biocompatibility - Dermal Sensitization | ISO 10993-10:2010(E) (Passes, Not a contact sensitizer) | Passes, Not a contact sensitizer under the conditions of the study. (Meets) |
| Watertight (1000ml) | ASTM D5151-06 (Passes) | Passes (Meets) |
| Intended Use | A disposable device for medical purposes, worn on hand/finger to prevent contamination. | Matches. |
| Material | ASTM D6319-10 (Nitrile) | Nitrile (Meets) |
| Color | - | Blue |
| Texture | - | Finger textured |
| Size | ASTM D6319-10 (Extra Small, Small, Medium, Large, Extra Large) | Extra Small, Small, Medium, Large, Extra Large (Meets) |
| Single Use | Medical Glove Guidance Manual - Labeling | Single use (Meets) |
Note: The acceptance criteria for Carmustine (BCNU) and Thiotepa are highlighted with a warning due to their extremely low permeation times, which the device matches.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each test (e.g., number of gloves tested for permeation, physical properties, etc.). However, the tests were conducted according to established ASTM standards (D6319-10, D6978-05, D6124-06, D5151-06) and ISO 10993-10:2010(E). These standards typically specify the minimum sample sizes required for such testing.
The provenance of the data is from WRP Asia Pacific Sdn Bhd, located in Sepang, Selangor Darul Ehsan, Malaysia (based on the submitter's address). The study is non-clinical performance data, indicating it's laboratory testing rather than data collected from patients. It is implicitly retrospective as it reports the results of tests already conducted.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this document. The "ground truth" here is based on objective, standardized laboratory measurements and performance against established ASTM and ISO standards, not on subjective expert consensus. No individual experts were used to establish ground truth in the way one would for diagnostic AI.
4. Adjudication Method for the Test Set
This is not applicable. The data presented are based on direct physical and chemical testing, adhering to specific methodologies outlined in the referenced standards. There is no ambiguous interpretation that would require an adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improve with AI vs without AI assistance
This is not applicable. This document concerns a physical medical device (examination gloves) and its material properties, not an AI or imaging diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) study was done
This is not applicable. This document describes the performance of a physical product and does not involve any algorithms or AI.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is established by objective measurements and adherence to recognized international standards. Specifically:
- ASTM D6319-10: Standard Specification for Nitrile Examination Gloves for Medical Application (for dimensions, physical properties, material).
- ASTM D6978-05: Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs (for chemotherapy drug permeation).
- ASTM D6124-06: Standard Test Method for Residual Powder on Medical Gloves (for powder freedom).
- ISO 10993-10:2010(E): Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (for biocompatibility).
- ASTM D5151-06: Standard Test Method for Detection of Holes in Medical Gloves (for watertightness).
8. The Sample Size for the Training Set
This is not applicable. This document describes the testing of a physical medical device, not a machine learning model. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established
This is not applicable, as there is no training set for this type of device submission.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 20, 2016
WRP Asia Pacific Sdn. Bhd. Sarala Devi Jayaraman Regulatory Affairs Manager Lot 1. Jalan 3. Kaw Perusahaan Bandar Baru Salak Tinggi, Sepang, 43900 MY
Re: K161422
Trade/Device Name: Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-sterile, Tested For Use With Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC Dated: September 15, 2016 Received: September 21, 2016
Dear Sarala Devi Javaraman:
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.
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
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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Michael J. Ryan -S
for Tina Kiang, Ph.D.
Acting Division Director Division of Anesthesiology, General Hospital, Respiratory Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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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 below.
510(k) Number (if known)
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 |
| Methotrexate | 25mg/ml | > 240 |
| Mitomycin C | 0.5mg/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)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
.
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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: 17 October 2016
2.0 Name of the modified device Identification:
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 | WRP Asia Pacific Sdn Bhd |
| Device name | Dermagrip Powder Free Blue Nitrile Patient ExaminationGloves, Non-sterile, Tested for use with ChemotherapyDrugs (and various brandnames) |
| 510(k) Number | K141982 |
| MDL | D236305 |
| Regulatory Class | I |
| Product Code | LZC, LZA |
4.0 Description of The Device:
Powder Free Blue Nitrile Patient Examination Glove, Non-Sterile the meets all requirements of ASTM standard D6319-10, D6978-05 and FDA 21 CFR 880.6250.
The powder free nitrile examination qlove is manufactured from synthetic rubber latex. Inner surface of gloves undergoes 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 glove surface. The glove is ambidextrous, i.e. can be worn on right hand or left hand. The physical properties of glove i.e. tensile strength meet ASTM standard D6319-10.
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5.0 Indications of Use:
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 Timein 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 |
| Methotrexate | 25 mg/ml | > 240 |
| Mitomycin C | 0.5 mg/ml | > 240 |
- Please note that the following drugs have extremely low permeation times: Carmustine (BCNU) : 15 minutes and Thiotepa : 2 minutes
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Summary of the Technological Characteristics of the Device: 6.0
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.
Table 1
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | |
|---|---|---|---|
| Predicate | Current | ||
| Manufacturer(s) | WRP Asia PacificSdn Bhd | WRP Asia PacificSdn Bhd | |
| 510(k) Number | K141982 | K161422 | |
| Dimensions | ASTM D6319-10 | Min 240mm | 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 |
| 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 | 15.0 |
| *Thiotepa | 10.0mg/ml | 2.0 | 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 |
| Methotrexate | 25 mg/ml | - | > 240 |
| Mitomycin C | 0.5 mg/ml | - | > 240 |
| Warning Statement | * WARNING: Pleasenote that thefollowing drugshave extremely lowpermeation times:Carmustine (BCNU): 15 minutes andThiotepa : 2minutes | * WARNING: Pleasenote that thefollowing drugs haveextremely lowpermeation times:Carmustine (BCNU): 15 minutes andThiotepa : 2minutes | |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | |
| Predicate | Current | ||
| Biocompatibility | Primary Skin Irritation- | Passes | Passes |
| ISO 10993-10:2010(E) | Not a primary skinirritant under theconditions of thestudy. | Not a primary skinirritant under theconditions of thestudy. | |
| Dermal Sensitization -ISO 10993-10:2010(E) | PassesNot a contactsensitizer under theconditions of thestudy. | PassesNot a contactsensitizer under theconditions of thestudy. | |
| Watertight (1000ml) | ASTM D5151-06 | Passes | Passes |
| Intended use | - | A patientexamination gloveis a disposabledevice intended formedical purposesthat is worn on theexaminer's hand orfinger to preventcontaminationbetween patientand examiner. | A patientexamination gloveis a disposabledevice intended formedical purposesthat is worn on theexaminer's hand orfinger to preventcontaminationbetween patientand examiner. |
| Material | ASTM D6319-10 | Nitrile | Nitrile |
| Color | - | Blue | Blue |
| Texture | - | Finger textured | Finger textured |
| Size | ASTM D6319-10 | 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
Clinical data was not needed for this device.
9.0 Conclusion
Based on intended uses, technological characteristics and non-clinical performance data, the subject device is substantially equivalent to the predicate device K141982.
§ 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.