(199 days)
Not Found
No
The document describes a standard patient examination glove and its performance against various ASTM standards and chemotherapy drug permeation. There is no mention of any computational or analytical capabilities, let alone AI or ML.
No.
This device, a patient examination glove, is intended to prevent contamination between the patient and examiner, not to provide therapy.
No
The device is a patient examination glove, intended to prevent contamination between patient and examiner. It does not perform any diagnostic function.
No
The device described is a physical medical device (patient examination glove) and does not involve any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device for personal protection and infection control.
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device that is used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The function of this device is to provide a physical barrier. It does not perform any diagnostic tests on patient samples.
- Testing Performed: The testing described (ASTM D6978-05 for chemotherapy drug permeation) relates to the protective properties of the glove, not to any diagnostic capability.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's health status.
The information about chemotherapy drug permeation testing is relevant to the glove's performance as a protective barrier when handling certain substances, but it does not make the glove an IVD.
N/A
Intended Use / Indications for 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
Product codes (comma separated list FDA assigned to the subject device)
LZC, LZA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner (medical purposes)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The device was tested for Chemo-therapy Drug Permeation as per ASTM D6978-05. Key results for breakthrough detection time in minutes are: Flourouracil (Adrucil) > 240, Etopside (Toposar) > 240, Cyclophosphamide (Cytoxan) > 240, Carmustine (BCNU) 15.0, Thiotepa 2.0, Paclitaxel (Taxol) > 240, Doxorubicin Hydrochloride (Adriamycin) > 240, Dacarbazine > 240, Cisplatin > 240, Ifosfamide > 240, Mitoxantrone > 240, Vincristine Sulfate > 240.
The device was tested for Biocompatibility for Primary Skin Irritation per ISO 10993-10:2010(E) & Consumer Product Safety Commission, Tittle 16, Chapter II, Part 1500, and for Dermal Sensitization per ISO 10993-10:2010(E) & Consumer Product Safety Commission, Tittle 16, Chapter II, Part 1500.3(c)(4). Both tests "Passes".
The device was tested for Watertight (1000ml) per ASTM D5151-06 and "Passes".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, with three overlapping faces suggesting community and connection. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the figure.
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.
1
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
2
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)
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the pata needed annound the and review the collection of information. Send comments regarding this burden estimate or any other opect of this information collection, including suggestions for reducing this burden, to:
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1.0 Submitter:
| Name: | Sarala Devi Jayaraman |
|---|---|
| Address: | WRP Asia Pacific Sdn Bhd |
| Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 | |
| Sepang, 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 Nitrile |
| Powder-Free Exam Gloves with a | |
| Chemotherapy 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.
5
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-Clark | ||
| Corporation | WRP Asia Pacific Sdn | ||
| Bhd | |||
| 510(k) Number | K081089 | K141982 | |
| Dimensions | ASTM D6319-10 | Conforms to ASTM | |
| 6319-00a | 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 Drug | |||
| Permeation Test | ASTM D6978-05 | ||
| Test Chemotherapy Drug | Concentration | Minimum Breakthrough Detection | |
| Time (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 that | |||
| the following | |||
| drugs have | |||
| extremely low | |||
| permeation times: | |||
| Carmustine | |||
| (BCNU) : 15 | |||
| minutes and | |||
| Thiotepa : 2 | |||
| minutes. | |||
| CHARACTERISTICS | |||
| STANDARDS | DEVICE PERFORMANCE | ||
| Predicate | Current | ||
| Biocompatibility | Primary Skin Irritation |
ISO 10993-
10:2010(E) &
Consumer Product
Safety Commission,
Tittle 16, Chapter II,
Part 1500 | Passes | Passes
Not a primary skin irritant
under the conditions of
the study. |
| | Dermal Sensitization -
ISO 10993-
10:2010(E) &
Consumer Product
Safety Commission,
Tittle 16, Chapter II,
Part 1500.3(c)(4) | Passes | Passes
Not a contact sensitizer
under the conditions of
the study. |
| Watertight (1000ml) | ASTM D5151-06 | Passes | Passes |
| Intended use | - | A patient
examination
glove is a
medical device
intended for
medical purposes
that is worn on
the examiner's
hand to prevent
contamination
between patient
and examiner. | 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. |
| Material | ASTM D6319-10 | Nitrile | Nitrile |
| Color | - | Light Gray | Blue |
| Texture | - | Textured Fingertip | Finger textured |
| Size | Medical Glove
Guidance Manual -
Labeling | 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 |
7
8
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.