(129 days)
Not Found
No
The document describes a standard examination glove and its testing for physical properties, chemical resistance, and skin irritation. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
No.
The device, a nitrile examination glove, is intended to prevent contamination between patient and examiner, not to treat a disease or condition.
No
Explanation: The device is a nitrile examination glove, which is a barrier intended to prevent contamination, not to diagnose a condition.
No
The device is a physical examination glove made of nitrile, clearly described as a hardware product.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is 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 for personal protection and contamination control, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description reinforces this by calling it a "patient examination glove" made from nitrile.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information. The testing described (ASTM standards for physical properties, biocompatibility, and chemotherapy drug permeation) is consistent with a medical device intended for barrier protection and safety, not an IVD.
Therefore, this device is a medical device, specifically a patient examination glove, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Gen 2 Nitrile 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.
Gen 2 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. 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. It is for over- the-counter use.
Product codes
LZA, LZC
Device Description
The subject device in this 510(k) Notification is Blue Nitrile Examination gloves, with claiming, this product contains 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 non-sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.
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
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
The Modified Draize -95 test 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
- ASTM D5151-06 (Freedom from Holes): AQL 2.5, Inspection Level G-1. Results: Meets ASTM D6319-10.
- ASTM D6319-10 (Dimensions, Physical Properties): Meets ASTM D6319-10 guidelines. Results: Meets ASTM D6319-10.
- ASTM D6124-06 (Powder-free residue):
§ 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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 20, 2020
ECO Medi Glove SDN BHD Suresh Kumar QA Manager Lot 23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, Perak, 34600 My
Re: K193121
Trade/Device Name: GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC Dated: December 14, 2020 Received: December 23, 2020
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 may, 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 aware 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Elizabeth Claverie-Williams, MS Assistant Director, THT4B2: Disinfection, Reprocessing and Personal Protection DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020 |
|-------------------------------------------------------------------------|-----------------------------------------------------------------|
| Indications for Use | See PRA Statement below |
510(k) Number (if known)
Device Name
Gen 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with Tested for use with Chemotherapy Drugs Claims
Indications for Use (Describe)
The Gen 2 Nitrile 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(µg/cm²/minute) |
|---|---|
| 1)Carmustine (BCNU)(3.3 mg/ml)(3,300ppm) | 22 |
| 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)Methotexale (25mg/ml)(25,000ppm) | 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) | 47.4 |
The Maximum testing time is 240 minutes. Please note that the following drugs have low permeation time:
-
Carmustine (BCNU)(3.3mg/ml)with Permeation time of 22 minutes.
-
Thiotepa ( 10.0mg/ml)with Permeation time of 47.4 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.
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 data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"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."
| FORM FDA 3881 (7/17) | Page 1 of 1 |
|---|---|
| ---------------------- | ------------- |
3
510(K) Summary Gen 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and Tested for use with Chemotherapy Drugs Claims
1.0 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 |
2.0 Preparation Date: 16th March 2020
3.0 Device Identification:
Trade Name / Proprietary Name: Gen 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for Use with Chemotherapy 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
4.0 Predicate Device:
Class I patient Examination glove with claiming, this product contain Low Dermatitis Potential Claim and tested for use with Chemotherapy Drugs, Powder Free, LZC, which meets all the requirement of ASTM D 6319-10 and FDA 21 CFR 880.6250.
Predicate Device: K152542, Powder Free Nitrile Examination (Blue) with Low Dermatitis Potential Claim with tested for use with Chemotherapy Drugs
5.0 Device Description:
The subject device in this 510(k) Notification is Blue Nitrile Examination gloves, with claiming, this product contains 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 non-sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.
6.0 Intended use of the Device:
Gen 2 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. 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. It is for over- the-counter use.
7.0 Specification for Nitrile gloves:
7.1 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 |
5
7.2 Gloves Physical Properties and Holes
| Measurement | Before Ageing | After Aging at 70℃ for
168 hrs @ 100℃ 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
7.3 Technological Characteristics Comparison Table:
| Characteristics | Acceptance Criteria | Subject | Predicate | Comparison |
|---|---|---|---|---|
| Gen 2 Nitrile Examination Gloves (Blue) with Low Dermatitis Potential Claim and with tested for use with chemotherapy drugs Claim, (K193121) | Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis Potential Claim and with tested for used with Chemotherapy Drugs, (K152542) | |||
| 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 |
| Non Sterile | Non Sterile | Non Sterile | Non Sterile | same |
6
| 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 | Meets ASTM D6319- 10 | Meets ASTM D6319-10 | same |
|--------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|---------|
| Physical properties | Before Ageing Tensile Strength
(MPa)
= 14min Ultimate
Elongation (%)
= 500min After Aging at 70°C for
168 hrs @ 100°C for 22 hrs
Tensile Strength (MPa)
= 14min Ultimate Elongation
(%)
= 400min | Meets ASTM
D6319-10 | Meets ASTM
D6319-10 | 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/glove | Meets ASTM
D6124-06 | Meets ASTM
D6124-06 | same |
| Biological Evaluation on
Medical Device - Part 10
-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 - Part 10
-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 | |
| Biological Evaluation on
Medical Device – Part 5
-Tests for in vitro
Cytotoxicity | Under the conditions of this
study, the test article was not
cytotoxic. | NA | Different | |
| Resistance against
Chemotherapy Drugs | 1) Carmustine (3.3mg/ml
or 3000ppm),
Breakthrough : 22 min. | 1) Carmustine (3.3mg/ml or
3000ppm), Breakthrough : 20.1
min. | similar | |
| | 2) Cyclophosphamide
(20mg/ml or 20,000ppm),
Breakthrough time :
240 min. | 2)Cyclophosphamide (20mg/ml or
20,000ppm),Breakthrough time :
240 min. | | |
| | 3) Cisplatin (1mg/ml or
1000ppm), Breakthrough
time :
240 min | 3) Cisplatin (1mg/ml or
1000ppm), Breakthrough time :
240 min | | |
| | 4)Doxorubicin Hydrochloride
(2.0mg/ml or 2000ppm),
Breakthrough time :
240 min. | 4)Doxorubicin Hydrochloride
(2.0mg/ml or 2000ppm),
Breakthrough time :
240 min. | | |
| | 5) Etoposide (20mg/ml or
20,000ppm), Breakthrough
time :
240 min. | 5) Etoposide (20mg/ml or
20,000ppm), Breakthrough time :
240 min. | | |
| | 6) Flourouracil (50mg/ml or
50,000), Breakthrough time :
240 min. | 6) Flourouracil (50mg/ml or
50,000), Breakthrough time :
240 min. | | |
| | | | | |
| | | 7) Methotexate (25mg/ml or 25,000ppm), Breakthrough time:
240 min. | 7) Methorexate (25mg/ml or 25,000ppm), Breakthrough time :
240 min. | |
| | | 8) Paclitaxel (6mg/ml or 6,000ppm), Breakthrough time:
240 min. | 8) Paclitaxel (6mg/ml or 6,000ppm), Breakthrough time:
240 min | |
| | | 9) Thiotepa (10mg/ml or 10,000ppm), Breakthrough time:
47.4 min. | 9) Thiotepa (10mg/ml or 10,000ppm), Breakthrough time:
50.6 min. | |
| 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 | similar |
7
8
Resistance against Chemotherapy Drugs
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection time
(Specimen 1/2/3)(Minutes) |
|----------------------------------------------------|------------------------------------------------------------------|
| 1)Carmustine (BCNU) (3.3mg/ml)(3,300 ppm) | 22 |
| 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)Methotexate(25.0mg/ml)(25,000 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) | 47.4 |
The maximum testing time is 240 minutes. Please note that the following drugs have extremely low permeation time. Carmustine (BCNU) (3.3mg/ml) Thiotepa (10mg/ml)
9
8.0) Summary of Non-Clinical Testing:
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D5151-06 | Freedom from | ||
| Holes | AQL 2.5 | ||
| Inspection Level G-1 | Meets ASTM D6319- | ||
| 10 | |||
| ASTM D6319-10 | Dimensions, | ||
| Physical Properties | ASTM D6319- 10 | Meets ASTM D6319- | |
| 10 | |||
| ASTM D6124-06 | Powder-free | ||
| residue |