(156 days)
Not Found
No
The device is a physical examination glove and the description focuses on material properties, biocompatibility, and resistance to chemotherapy drugs. There is no mention of AI or ML.
No.
The device, which is a nitrile examination glove, is intended to prevent contamination between the patient and examiner, and is tested for resistance to chemotherapy drugs. It does not perform a therapeutic function in treating or curing a disease or condition.
No
The device is described as a "Nitrile Powder Free Examination Glove" intended to prevent contamination between the patient and examiner, and tested for use with chemotherapy drugs. Its purpose is protective, not diagnostic.
No
The device description clearly states it is a physical glove made from nitrile compound, which is a hardware component.
No, 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 purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner." This describes a barrier device used during medical examinations or procedures.
- Device Description: The description details a "patient examination glove made from nitrile compound." This is a physical barrier device.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This glove does not perform any such function. It is a physical barrier.
- Performance Studies: The performance studies focus on the physical properties of the glove (strength, freedom from pinholes), biocompatibility (skin irritation, sensitization), and resistance to chemotherapy drugs. These are relevant to a barrier device, not an IVD.
The information provided consistently describes a medical glove, which is a Class I medical device used as a physical barrier, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Nitrile Powder Free Examination Glove (Blue) with Low Dermatitis Potential Claim is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner. In addition these gloves was tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards, Practice for assessment of medical glove to Permeation by Chemotherapy Drugs.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC
Device Description
The subject device in this 510(k) Notification is Blue Nitrile Examination gloves, with Low Dermatitis Potential Claim and tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from nitrile compound, Blue color, powder free and nonsterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, ASTM D5151-06, ASTM D6124-06, and ASTM D6978-05 and Modified Draize 95 test.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands 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
Testing was performed per ASTM D6319-10 , ASTM D5151-06, ASTM D6124-06,ISO 10993-10:2010 . ISO10993-5 and 16 CFR Part 1500.41.
Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and tested for Use with Chemotherapy drugs were tested in accordance with Modified Draize -95 test , per FDA's guidance document "Guidance for Industry and FDA Reviewer/Staffs: Premarket Notification [510k] Submissions for testing for skin sensitization to chemical in natural Rubber Products".
The study was conducted in two stages. In the first, a population of 30 human subjects was tested to evaluate the product for the potential to cause irritation or sensitization. The second stage was initiated on a further number of subjects to a total of a minimum 205 individuals after the first stage has shown that the test product does not indicate a potential for inducing dermal irritation and does not shown sensitization capability
The study completed on 205 non sensitized adult human subjects, who reasonably reflect the general user population in the US, gave all negative results.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The study completed on 205 non sensitized adult human subjects, who reasonably reflect the general user population in the US, gave all negative results. There was no clinical evidence of the presence of residual chemical additives at the level that may induce type IV allergy in the un-sensitized general user population in the tested articles.
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 26, 2018
ECO Medi Glove Sdn Bhd Suresh Kumar Quality Assurance Manager Lot 23826, Jalan Tembaga Kuning Kamunting Raya Industrial Estate Perak, 34600 My
Re: K181066
Trade/Device Name: Powder Free Examination Glove (Blue) with Low Dermatitis claim and with tested for use with Chemotherapy Drugs Claims Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: August 18, 2018 Received: August 27, 2018
Dear Suresh Kumar:
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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Clarence W. Murray lii III -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181066
Device Name
Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with Chemotherapy Drugs Claims
Indications for Use (Describe)
The Nitrile Powder Free Examination Glove (Blue) with Low Dermatitis Potential Claim is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner. In addition these gloves was tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards, Practice for assessment of medical glove to Permeation by Chemotherapy Drugs.
Chemotherapy Drugs and Concentration
Minimum Breakthrough detection time in minutes(ug/cm2/minute)
| 1)Carmustine (BCNU)(3.3 mg/ml)(3,300ppm) | 12.9 |
|---|---|
| 2)Cisplatin (1.0 mg/ml)(1,000ppm) | No breakthrough up to 240 min |
| 3)Cyclophosphamide (Cytoxan)(20 mg/ml)(20,000ppm) | No breakthrough up to 240 min |
| 4)Dacarbazine (DTIC) (10.0 mg/ml)(10,000ppm) | No breakthrough up to 240 min |
| 5)Doxorubicin Hydrochloride (2.0 mg/ml)(2,000ppm) | No breakthrough up to 240 min |
| 6)Etoposide (Toposar)(20.0 mg/ml)(20,000ppm) | No breakthrough up to 240 min |
| 7)Fluorouracil (50.0 mg/ml)(50,000ppm) | No breakthrough up to 240 min |
| 8)Paclitaxel (Taxol)(6.0 mg/ml)(6,000ppm) | No breakthrough up to 240 min |
| 9)Thiotepa (10.0 mg/ml)(10,000ppm) | 24.7 |
The Maximum testing time is 240 minutes. Please note that the following drugs have low permeation time: 1)Carmustine (BCNU)(3.3mg/ml)with Permeation time of 12.9 minutes. 2)Thiotepa ( 10.0mg/ml)with Permeation time of 24.7 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) |
_ | Prescription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(K) Summary for K181066 Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with Tested for use with Chemotherapy Drugs Claims
1. Submitter:
| Company Name: | ECO Medi Glove Sdn Bhd. |
|---|---|
| Company Address: | Lot 23826, Jalan Tembaga Kuning |
| Kamunting Raya Industrial Estate, | |
| 34600, Taiping | |
| Perak, Malaysia | |
| Contact Person: | Mr Suresh Kumar |
| Telephone No: | 603-60283033 |
| Email: | qa1@riverstone.com.my |
2. Preparation Date : 12th September 2018
3. Name of the Device
| Trade Name / Proprietary Name: | Powder Free Nitrile Examination Glove (Blue)
With Low Dermatitis Potential Claim and with tested
for Use with hemotherapy drugs Claims. |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name : | Nitrile Patient Examination gloves. |
| Device Classification Name : | Patient Examination gloves (21 CFR 880.6250). |
| Device Class : | Class I. |
| Product Code : | LZA , LZC. |
4. Identification of The Legally Marketed Device:
Predicate Device: K152542, Powder Free Nitrile Examination (Blue) with Low Dermatitis Potential Claim with tested for use with Chemotherapy Drugs
5. Device Description
The subject device in this 510(k) Notification is Blue Nitrile Examination gloves, with Low Dermatitis Potential Claim and tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from nitrile compound, Blue color, powder free and nonsterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, ASTM D5151-06, ASTM D6124-06, and ASTM D6978-05 and Modified Draize 95 test.
4
Indication for Use:
The Nitrile Powder Free Examination Glove (Blue) with Low Dermatitis Potential Claim is a disposable device intended for medical purpose that is worn on the examiner's hands 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 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.
| Test Chemotherapy Drug and Concentration | Minimum Breakthrough Detection time in
minutes |
|----------------------------------------------------|---------------------------------------------------|
| 1)Carmustine (BCNU) (3.3mg/ml)(3,300 ppm) | 12.9 |
| 2) Cisplatin (1.0mg/ml)(1,000 ppm) | No breakthrough up to 240 min |
| 3)Cyclophosphamide (Cytoxan)(20mg/ml)(20,000 ppm) | No breakthrough up to 240 min |
| 4)Dacarbazine (DTIC)(10.0mg/ml)(10,000 ppm) | No breakthrough up to 240 min |
| 5)Doxorubicin Hydrochloride ( 2.0mg/ml)(2,000 ppm) | No breakthrough up to 240 min |
| 6)Etoposide (Toposar)(20.0mg/ml)(20,000 ppm) | No breakthrough up to 240 min |
| 7)Fluorouracil (50.0mg/ml)(50,000 ppm) | No breakthrough up to 240 min |
| 8)Paclitaxel (Taxol)(6.0mg/ml)(6,000 ppm) | No breakthrough up to 240 min |
| 9)Thiotepa(10.0mg/ml)(10,000 ppm) | 24.7 |
Maximum testing time is 240 minutes. Please note that the following drugs have extremely low permeation time.
-
Carmustine (BCNU) (3.3mg/ml) with Permeation time of 12.9 minutes.
-
Thiotepa (10mg/ml) with Permeation time of 24.7 minutes
6. Specification for Nitrile gloves:
6.1.1 Dimension and Thickness of Gloves
| Dimension | Size S | Size M | Size L | Size XL |
|---|---|---|---|---|
| Overall Length (mm) | 230min | 230min | 230min | 230min |
| Width (± 5mm) | 85 | 95 | 105 | 115 |
| Thickness at Palm (mm) | 0.05min | 0.05min | 0.05min | 0.05min |
| Thickness at Finger Tip (mm) | 0.05min | 0.05min | 0.05min | 0.05min |
6.1.2 Gloves Physical Properties and Holes
| Measurement | Before Ageing | After Aging at 70°C for
168 hrs @ 100°C for 22 hrs |
|-------------------------|---------------------------------|-------------------------------------------------------|
| Tensile Strength (MPa) | 14min | 14 Min |
| Ultimate Elongation (%) | 500min | 400min |
| Pin-hole Level | AQL 2.5
Inspection Level G-1 | AQL 2.5
Inspection Level G-1 |
Gloves meet all the specification listed in ASTM D 6319-10
6.1.3 Summary of the Technological Characteristics of the Device
5
| Characteristics | Acceptance Criteria | Powder Free Nitrile
Examination Gloves(Blue) with
Low Dermatitis Potential Claim
and with tested for use with
chemotherapy drugs Claim,
K181066 | Powder Free Nitrile
Examination Glove (Blue) with
Low Dermatitis Potential Claim
and with tested for used with
Chemotherapy Drugs ,K152542 | Comparison |
|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product Code | LZA, LZC | LZA, LZC | LZA, LZC | Same |
| Intended use | A powder free 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. The device is
for over-the-counter use. | A powder free 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. The device
is for over-the-counter use. | A powder free 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. The device
is for over-the-counter use. | Same |
| Material use | Nitrile
compound | Nitrile
compound | Nitrile
compound | Same |
| Colour | Blue | Blue | Blue | Same |
| Sterility | Non sterile | Non sterile | Non sterile | Same |
| Single used | Single used | Single used | Single used | Same |
| Dimensions | Overall Length (mm)
Min 230mm
Width (± 5mm)
Size S = 85mm
Size M = 95mm
Size L = 105mm
Size XL = 115mm
Thickness at Palm (mm)
Min; 0.05 mm
Thickness at Finger Tip (mm)
Min 0.05 mm | Min 230mm | Min 230mm | Same |
| Physical properties | Before Ageing
Tensile Strength (MPa)
= 14min
Ultimate Elongation (%)
= 500min
After Aging at 70ºC for
168 hrs @ 100℃ for 22 hrs
Tensile Strength (MPa)
= 14min
Ultimate Elongation (%)
= 400min | Before aging :
Tensile strength: Min 14 Mpa
Ultimate Elongation : Min 500%
After Aging :
Tensile strength: Min 14 Mpa
Ultimate Elongation : Min 400% | Before aging :
Tensile strength: Min 14 Mpa
Ultimate Elongation : Min 500%
After Aging :
Tensile strength: Min 14 Mpa
Ultimate Elongation : Min 400% | Same |
| Freedom from
pinholes | AQL 2.5
Inspection Level G-1 | Meets ASTM D5151-06 | Meets ASTM D5151-06 | Same |
| Residual Powder | ≤ 2.0 mg/pc | ≤ 2.0 mg/pc | ≤ 2.0 mg/pc | Same |
| Biological
Evaluation on
Medical Device -
-Primary Skin
Irritation Test | | Under the conditions of this
study, the test article was a non-
irritant. | Under the conditions of this
study, the test article was a non-
irritant. | Same |
| Biological
Evaluation on
Medical Device -
Dermal
Sensitization
Assay | | Under the conditions of this study,
the test article was a non-sensitizer. | Under the conditions of this study,
the test article was a non-sensitizer. | Same |
| ISO 10993-5:2009 | Biological Evaluation of Medical
Device -Part 5: Test for In Vitro
Cytotoxicity | Under the conditions of this study,
the test article was not cytotoxic. | No test done | Similar |
| Resistance
against
Chemotherapy
Drugs | | 1) Carmustine (3.3mg/ml or
3000ppm), Breakthrough : 12.9 min.
2) Cyclophosphamide (20mg/ml or
20,000ppm), Breakthrough time:
240 min.
- Cisplatin (1mg/ml or 1000ppm),
Breakthrough time > 240 min
4)Doxorubicin Hydrochloride
(2.0mg/ml or 2000ppm),
Breakthrough time >240 min. - Etoposide (20mg/ml or
20,000ppm), Breakthrough time:
240 min.
- Flourouracil (50mg/ml or 50,000),
Breakthrough time :>240 min. - Dacarbazine (DTIC) (10mg/ml or
10,000ppm), Breakthrough time: >
240 min. - Paclitaxel (6mg/ml or 6,000ppm),
Breakthrough time >240 min. - Thiotepa (10mg/ml or
10,000ppm), Breakthrough time:24.7
min. | 1) Carmustine (3.3mg/ml or
3000ppm), Breakthrough 20.1 min. - Cyclophosphamide
(20mg/ml or 20,000ppm),
Breakthrough time: >240 min. - Cisplatin (1mg/ml or 1000ppm),
Breakthrough time: >240 min
4)Doxorubicin Hydrochloride
(2.0mg/ml or 2000ppm),
Breakthrough time: >240 min. - Etoposide (20mg/ml or
20,000ppm), Breakthrough time:
240 min.
- Flourouracil (50mg/ml or 50,000),
Breakthrough time : >240 min. - Methotrexate (25mg/ml or
25,000ppm), Breakthrough time: >
240 min. - Paclitaxel (6mg/ml or 6,000ppm),
Breakthrough time:>240 min. - Thiotepa (10mg/ml or
10,000ppm), Breakthrough time:
50.6 min. | Difference |
| Low Dermatitis
Potential Claim | 1)Modified Draize 95 test | No Clinical evidence presence of
residual chemical additives that
may induce Type IV allergy in
human subject | No Clinical evidence presence of
residual chemical additives that
may induce Type IV allergy in
human subject | Same |
6
7. Summary of Non-Clinical Performance data
Testing was performed per ASTM D6319-10 , ASTM D5151-06, ASTM D6124-06,ISO 10993-10:2010 . ISO10993-5 and 16 CFR Part 1500.41. The glove meets standards requirement referenced in section 6.0 above. Biocompatibility test indicates the gloves are not a contact skin sensitizer, not a primary skin irritant, and not cytotoxic.
8. Summary of Clinical Performance Data
Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and tested for Use with Chemotherapy drugs were tested in accordance with Modified Draize -95 test , per FDA's guidance document "Guidance for Industry and FDA Reviewer/Staffs: Premarket Notification [510k] Submissions for testing for skin sensitization to chemical in natural Rubber Products".
7
The study was conducted in two stages. In the first, a population of 30 human subjects was tested to evaluate the product for the potential to cause irritation or sensitization. The second stage was initiated on a further number of subjects to a total of a minimum 205 individuals after the first stage has shown that the test product does not indicate a potential for inducing dermal irritation and does not shown sensitization capability
The study completed on 205 non sensitized adult human subjects, who reasonably reflect the general user population in the US, gave all negative results. There was no clinical evidence of the presence of residual chemical additives at the level that may induce type IV allergy in the un-sensitized general user population in the tested articles.
9. Conclusion
The conclusions drawn from the nonclinical and clinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.