(150 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of a patient examination glove, with no mention of AI or ML technology.
No.
The device is a patient examination glove, intended to prevent contamination between patient and examiner, not to treat or cure a disease or condition.
No.
The device is described as a "patient examination glove," which is a barrier device intended to prevent contamination between the patient and examiner, not to diagnose a medical condition.
No
The device is a physical glove, not software. The description details material properties and physical standards, not software functions.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body.
- Device Function: The device described is a patient examination glove. Its purpose is to be worn on the hand or finger to prevent contamination between the patient and the examiner. It is a barrier device used on the body (the examiner's hand) during a physical examination.
- Intended Use: The intended use clearly states it's for preventing contamination during a patient examination. This is a physical barrier function, not a diagnostic test performed on a specimen.
- Device Description: The description focuses on the physical properties and materials of the glove, not on any diagnostic capabilities.
- Performance Studies and Metrics: The performance studies and metrics relate to the glove's physical integrity, barrier properties (like chemotherapy drug permeation and watertightness), and biocompatibility. These are relevant to a protective barrier device, not an IVD.
The fact that it's tested for use with chemotherapy drugs relates to its barrier function and safety for the user when handling such substances, not to any diagnostic capability.
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)
LZA, LZC
Device Description
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.
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 / Not Found
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:
- Dimensions (ASTM D6319-10): Min 240mm (Meets)
- Physical Properties (ASTM D6319-10): Meets
- Thickness - Finger: 0.07 - 0.10mm
- Thickness - Palm: 0.07 - 0.09mm
- Thickness - Cuff: 0.06 - 0.08mm
- Powder Free (ASTM D6124-06 (≤ 2 mg/glove)): Meets
- Chemotherapy Drug Permeation Test (ASTM D6978-05):
- Flourouracil (Adrucil) 50.0mg/ml: > 240 minutes
- Etopside (Toposar) 20.0mg/ml: > 240 minutes
- Cyclophosphamide (Cytoxan) 20.0mg/ml: > 240 minutes
- *Carmustine (BCNU) 3.3mg/ml: 15.0 minutes
- *Thiotepa 10.0mg/ml: 2.0 minutes
- Paclitaxel (Taxol) 6.0mg/ml: > 240 minutes
- Doxorubicin Hydrochloride (Adriamycin) 2.0mg/ml: > 240 minutes
- Dacarbazine 10.0mg/ml: > 240 minutes
- Cisplatin 1.0mg/ml: > 240 minutes
- Ifosfamide 50.0mg/ml: > 240 minutes
- Mitoxantrone 2.0mg/ml: > 240 minutes
- Vincristine Sulfate 1.0mg/ml: > 240 minutes
- Methotrexate 25 mg/ml: > 240 minutes
- Mitomycin C 0.5 mg/ml: > 240 minutes
- Biocompatibility (Primary Skin Irritation - ISO 10993-10:2010(E)): Passes, Not a primary skin irritant under the conditions of the study.
- Biocompatibility (Dermal Sensitization - ISO 10993-10:2010(E)): Passes, Not a contact sensitizer under the conditions of the study.
- Watertight (1000ml) (ASTM D5151-06): 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 caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is simple and recognizable, and it is used to represent the U.S. Department of Health & Human Services.
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
1
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
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 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.
.
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 and complete and review the collection of information. Send comments regarding this burden estimate or any other spect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
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: 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 Examination |
| Gloves, Non-sterile, Tested for use with Chemotherapy | |
| Drugs (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.
5
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 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 | 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
6
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 Pacific | ||
| Sdn Bhd | WRP Asia Pacific | ||
| Sdn 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 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 | 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: Please | ||
| note that the | |||
| following drugs | |||
| have extremely low | |||
| permeation times: | |||
| Carmustine (BCNU) | |||
| : 15 minutes and | |||
| Thiotepa : 2 | |||
| minutes | * 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 |
-
| Passes | Passes |
| | ISO 10993-
10:2010(E) | Not a primary skin
irritant under the
conditions of the
study. | Not a primary skin
irritant under the
conditions of the
study. |
| | Dermal Sensitization -
ISO 10993-
10:2010(E) | Passes
Not a contact
sensitizer under the
conditions of the
study. | 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 disposable
device intended for
medical purposes
that is worn on the
examiner's hand or
finger 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 | - | Blue | Blue |
| Texture | - | Finger textured | Finger textured |
| Size | ASTM D6319-10 | 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
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.