(272 days)
Not Found
No
The device description and performance studies focus on the physical properties, biocompatibility, and chemical resistance of examination gloves, with no mention of AI or ML technologies.
No
The device is described as an examination glove intended to prevent contamination between patient and examiner, and for protection against chemotherapy drugs, rather than to treat a disease or condition.
No
This device is a Nitrile Examination Glove, a barrier device intended to prevent contamination between the patient and examiner. Its purpose is not to diagnose any condition or disease.
No
The device description clearly states the device is a physical product, Nitrile Examination Gloves, and the performance studies focus on physical and chemical properties, not software functionality.
Based on the provided text, 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 hand or finger to prevent contamination between patient and examiner." This describes a barrier device for protection, not a device used to examine specimens from the human body to provide diagnostic information.
- Device Description: The description focuses on the physical properties of the glove (material, color, powder-free, sterile) and its testing for physical performance and resistance to chemotherapy drugs. There is no mention of analyzing biological samples or providing diagnostic results.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or treatment decisions
- Reagents or assays
The testing performed (dimensions, physical properties, pinholes, powder, biocompatibility, chemotherapy drug resistance) are all related to the physical integrity and safety of the glove as a barrier device, not its ability to perform a diagnostic test.
N/A
Intended Use / Indications for Use
The Nitrile Examination gloves,is a disposable device intended for medical purpose 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.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC
Device Description
The subject device in this 510(k) Notification is Nitrile Examination Gloves Sterile with tested for use with Chemotherapy drugs claims. The subject device is a patient examination glove made from nitrile latex compound, white colour, powder free and sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility per ISO 10993-5, 10993-10, 10993-11 and permeability to chemotherapy drugs per ASTM D6978-05.
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 purpose)
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)
Non-clinical testing was performed to verify that the subject device will meet the acceptance criteria of the performance test shown below:
Technological Characteristics: Dimensions, Standard/Test/FDA Guidance: ASTM D6319-10, Result Summary: Meets
Technological Characteristics: Physical properties, Standard/Test/FDA Guidance: ASTM D6319-10, Result Summary: Meets
Technological Characteristics: Freedom from pinholes, Standard/Test/FDA Guidance: ASTM D6319-10, Result Summary: Meets
Technological Characteristics: Residual Powder, Standard/Test/FDA Guidance: ASTM D5151-06, Result Summary: Meets
Technological Characteristics: Biological Evaluation on Medical Device-Primary Skin Irritation Test, Standard/Test/FDA Guidance: ISO 10993-10, Result Summary: Meets
Technological Characteristics: Biological Evaluation on Medical Device-Dermal Sensitization Assay, Standard/Test/FDA Guidance: ISO 10993-10, Result Summary: Meets
Technological Characteristics: Acute Systemic Toxicity, Standard/Test/FDA Guidance: ISO 10993-11, Result Summary: Meets
The subject device meets the applicable requirements for patients gloves with regards to dimension and sizes, physical properties, freedom from holes and powder Residuals as found in the following standards: ASTM D6139, ASTM D5151, ASTM D6124.The subject device passes biological reactivity testing for dermal sensitization, irritation and acute systemic toxicity with accordance ISO10993-10 AND ISO 10993-11.
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.
December 17, 2019
Riverstone Resources SDN BHD Suresh Kumar QA Manager Lot 56, No 15, Jalan Jasmin 2 Bukit Beruntung, 48300 My
Re: K190725
Trade/Device Name: Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC Dated: November 14, 2019 Received: November 18, 2019
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.
1
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 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 medical devices and radiation-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.
For Elizabeth Claverie, M.S. Assistant Director for THT4B2 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
Indications for Use
510(k) Number (if known) K190725
Device Name
Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White.
Indications for Use (Describe)
The Nitrile Examination gloves,is a disposable device intended for medical purpose 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.
Chemotherapy Drug and Concentration
Minimum Breakthrough detection time in Minutes
-
- Carmustine (BCNU)(3.3mg/ml) 39 minutes 2) Cyclophosphamide (20mg/ml) > 240 minutes 3) Cisplatin (1.0mg/ml) > 240 minutes 4) Doxorubicin Hydrochloride (2.0mg/ml) > 240 minutes > 240 minutes 5) Etoposide (20mg/ml) 6) Fluorouracil (50mg/ml) > 240 minutes 7) Methorexate (25mg/ml) > 240 minutes > 240 minutes 8) Paclitaxel (6mg/ml) 9) Thiotepa (10mg/ml) 97.6 minutes
Caution:
Thiotepa (10mg/ml),Breakthrough Detected at 97.6 Minutes Carmustine (3.3mg/ml),Breakthrough Detected at 39 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)
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:
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."
3
Lot 55, No 13, Jalan Jasmin 2, Kawasan Perindustrian Bukit Beruntung,
48300 Bukit Beruntung. Selangor
510k No:K190725
510(K) Summary Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs claim,White
1.0 Submitter :
| Company Name | : RIVERSTONE RESOURCES SDN BHD |
|---|---|
| Company Address | : Lot 55, No 13, Jalan Jasmin 2, |
| Kawasan Perindustrian Bukit Beruntung | |
| 48300,Bukit Beruntung Selangor | |
| Malaysia. | |
| Contact Person | : Mr Suresh Kumar |
| Telephone No | : 603-60283033 |
| : qa1@riverstone.com.my |
2.0 Preparation Date : 11th December 2019
3.0 Name of the Device
Trade Name / Proprietary Name: Nitrile Examination Glove Sterile tested for use with Chemotherapy Drugs claims,White
Device Name: Nitrile Patient Examination gloves.
Device Classification Name: Patient Examination gloves (21 CFR 880.6250).
Device Class: Class I.
Product Code: LZA and LZC.
4
Lot 55, No 13, Jalan Jasmin 2, Kawasan Perindustrian Bukit Beruntung, 48300 Bukit Beruntung. Selangor
510k No:K190725
4.0) Identification of The Legally Marketed Device:
K180452, White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim
5.0 Device Description
The subject device in this 510(k) Notification is Nitrile Examination Gloves Sterile with tested for use with Chemotherapy drugs claims. The subject device is a patient examination glove made from nitrile latex compound, white colour, powder free and sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility per ISO 10993-5, 10993-10, 10993-11 and permeability to chemotherapy drugs per ASTM D6978-05.
6.0 Indications for Use
The Nitrile Examination gloves, is a disposable device intended for medical purpose 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.
| Chemotherapy Drug and concentration | Minimum Breakthrough detection time |
|---|---|
| in Minutes | |
| 1)Carmustine (BCNU) (3.3mg/ml) | 39 minutes |
| 2)Cyclophosphamide (20mg/ml) | > 240 minutes |
| 3)Cytarabine (10mg/ml) | > 240 minutes |
| 4)Doxorubicin Hydrochloride (2 mg/ml) | > 240 minutes |
| 5)Etoposide (20mg/ml) | > 240 minutes |
| 6)Fluorouracil (50mg/ml) | > 240 minutes |
| 7)Methorexate (25mg/ml) | > 240 minutes |
| 8) Paclitaxel (6mg/ml) | > 240 minutes |
| 9) Thiotepa (10mg/ml) | 97.6 minutes |
Caution:
Thiotepa (10mg/ml), Breakthrough Detected at 97.6 Minutes Carmustine (3.3mg/ml), Breakthrough Detected at 39 Minutes
5
Lot 55, No 13, Jalan Jasmin 2, Kawasan Perindustrian Bukit Beruntung,
48300 Bukit Beruntung. Selangor
510k No:K190725
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) (Minimum) | 230 | 230 | 230 | 230 |
| Width (± 5mm) | 85 | 95 | 105 | 115 |
| Thickness at Palm (mm) (Minimum) | 0.05 | 0.05 | 0.05 | 0.05 |
| Thickness at Finger Tip (mm)(Minimum) | 0.05 | 0.05 | 0.05 | 0.05 |
7.2 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
7.3 Summary of the Technological Characteristics of the Device compared to the Predicate Device
| Characteristics | Acceptance
Criteria | Nitrile Examination
Glove Sterile tested
for use with
chemotherapy
drugs claim, White
K190725 | White Nitrile
Examination
Gloves Sterile
Tested For Used
With
Chemotherapy
Drugs Claim,
K180452 | Comparison |
|-----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | LZA and LZC | LZA and LZC | LZA and LZC | Same |
| | | | 510k No:K190725 | |
| 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 |
| Description | | Sterile Examination
glove made of
Nitrile and color
White and tested
with chemotherapy
Drugs | Sterile
Examination
glove made of
Nitrile and color
White | Same |
| Presentation | | Sterile gloves are
provided in Pouches | Sterile gloves are
provided in
Pouches | Same |
| Ambidextrous | | Yes | Yes | Same |
| Material use | Nitrile Synthetic
Latex | Nitrile Synthetic
Latex | Nitrile Synthetic
Latex | Same |
| Colour | | White | White | Same |
| Sterility | Sterility
ISO 11737-
2:2009
EN ISO 11137-
2:2015 | Sterility | Sterility | Same |
| Single used | | Single used | Single used | Same |
| Non Sterile or
Sterile | | Sterile | Sterile | Same |
| | 510k No:K190725 | | | |
| Dimensions | Overall Length
(mm)
Min 230 mm
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
ASTM D6319-10 | Meets ASTM
D5151-06 | Meets ASTM
D5151-06 | Same |
| Residual
Powder | 240 µg/cm²/minute
- Cisplatin (1.0mg/ml or 1,000ppm), Minimum Breakthrough detection time: >240 µg/cm²/minute
4)Doxorubicin Hydrochloride (2.0mg/l), Minimum Breakthrough detection time: >240 µg/cm²/minute
-
Etoposide | 1) Carmustine (3.3mg/ml or 3000ppm), Minimum Breakthrough detection time : 17.1 µg/cm²/minute
-
Cyclophosphamide (20mg/ml or 20,000ppm), Minimum Breakthrough detection time: >240 µg/cm²/minute
-
Cisplatin (1.0mg/ml or 1,000ppm), Minimum Breakthrough detection time: >240 µg/cm²/minute
4)Doxorubicin Hydrochloride (2.0mg/ml or 2000ppm), Minimum | Similar |
| | (20mg/ml or
20,000ppm),
Minimum
Breakthrough
detection time: >240
µg/cm²/minute
-
Flourouracil
(50mg/ml or
50,000), Minimum
Breakthrough
detection time: >240
µg/cm²/minute -
Paclitaxel
(6mg/ml or
6,000ppm),
Minimum
Breakthrough
detection time: >240
µg/cm²/minute -
Thiotepa
(10mg/ml or
10,000ppm),
Minimum
Breakthrough
detection time: 97.6
µg/cm²/minute -
Methotrexate (25
mg/ml ),
Minimum
Breakthrough
detection time: >240
µg/cm²/minute | Breakthrough
detection time:
240
µg/cm²/minute
- Etoposide
(20mg/ml or
20,000ppm),
Minimum
Breakthrough
detection time:
240
µg/cm²/minute
- Flourouracil
(50mg/ml or
50,000),
Minimum
Breakthrough
detection time:
240
µg/cm²/minute
- Paclitaxel
(6mg/ml or
6,000ppm),
Minimum
Breakthrough
detection time:
240
µg/cm²/minute
-
Thiotepa
(10mg/ml or
10,000ppm),
Minimum
Breakthrough
detection time:
56.9
µg/cm²/minute -
Dacarbazine
(1.0 mg/ml ),
Minimum
Breakthrough
detection time:
240
µg/cm²/minute | | |
6
Lot 55, No 13, Jalan Jasmin 2, Kawasan Perindustrian Bukit Beruntung,
48300 Bukit Beruntung. Selangor
510k No:K190725
7
Lot 55, No 13, Jalan Jasmin 2, Kawasan Perindustrian Bukit Beruntung,
48300 Bukit Beruntung. Selangor
8
Lot 55, No 13, Jalan Jasmin 2, Kawasan Perindustrian Bukit Beruntung,
48300 Bukit Beruntung. Selangor
510k No:K190725
9
Lot 55, No 13, Jalan Jasmin 2, Kawasan Perindustrian Bukit Beruntung,
48300 Bukit Beruntung. Selangor
510k No:K190725
10
Lot 55, No 13, Jalan Jasmin 2, Kawasan Perindustrian Bukit Beruntung,
48300 Bukit Beruntung. Selangor
510k No:K190725
8.0 Summary of Non-Clinical Testing.
Non-clinical testing was performed to verify that the subject device will meet the acceptance criteria of the performance test shown below:
| Technological Characteristics | Standard/Test/FDA Guidance | Result Summary |
|---|---|---|
| Dimensions | ASTM D6319-10 | Meets |
| Physical properties | ASTM D6319-10 | Meets |
| Freedom from pinholes | ASTM D6319-10 | Meets |
| Residual Powder | ASTM D5151-06 | Meets |
| Biological Evaluation on | ||
| Medical Device | ||
| -Primary Skin Irritation Test | ISO 10993-10 | Meets |
| Biological Evaluation on | ||
| Medical Device- | ||
| Dermal Sensitization Assay | ISO 10993-10 | Meets |
| Acute Systemic Toxicity | ISO 10993-11 | Meets |
The subject device meets the applicable requirements for patients gloves with regards to dimension and sizes, physical properties, freedom from holes and powder Residuals as found in the following standards: ASTM D6139, ASTM D5151, ASTM D6124.The subject device passes biological reactivity testing for dermal sensitization, irritation and acute systemic toxicity with accordance ISO10993-10 AND ISO 10993-11
9.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed device.