(68 days)
Not Found
No
The device is a medical glove, and the description and testing focus on material properties and performance standards for gloves, with no mention of AI or ML.
No
The device is described as a disposable "medical glove" intended to "prevent contamination between examiner and patient," which classifies it as a barrier device for examination and protection, not a device that treats, cures, or rehabilitates.
No
Explanation: The device is described as a medical glove intended to prevent contamination between examiner and patient, which is a barrier function, not a diagnostic one. It does not mention any capability for detecting, identifying, or analyzing medical conditions or disease.
No
The device is a physical glove made of nitrile, not software. The description focuses on material standards and physical performance tests.
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 Intended Use: The intended use of these gloves is to be worn on the examiner's hand or finger to prevent contamination between the examiner and the patient. This is a barrier function, not a diagnostic test performed on a specimen.
- Device Description: The description focuses on the physical properties and standards met by the glove, not on any diagnostic capabilities.
- Lack of IVD-related information: The document does not mention any analysis of biological samples, diagnostic markers, or any other elements typically associated with IVD devices.
This device is clearly a medical glove, which is a type of medical device used for protection and hygiene, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential is a medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between examiner and patient.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential meet ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dermatitis
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were conducted to demonstrate that the proposed device met all design specifications. The test results demonstrated that the proposed device met the performance criteria with the following standards:
- Physical Dimensions/Thickness: ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application, Passed.
- Physical Properties: ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application, ASTM D412-16(2021) Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-Tension, Passed.
- Powder Residue: ASTM D6124-06(2022) Standard Test Method for Residual Powder on Medical Gloves, Passed.
- Freedom from Holes: ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves, Passed.
- Irritation: ISO 10993-23:2021 Biological evaluation of medical devices Part 23: Tests for irritation, Under the conditions of the study, the device was not an irritant.
- Sensitization: ISO 10993-10:2021 Biological evaluation of medical devices Part 10: Tests for skin sensitization, Under the conditions of the study, the device was not a sensitizer.
- Cytotoxicity: ISO 10993-5 Biological evaluation of medical devices-Part 5 Tests for in vitro cytotoxicity, Under the conditions of the study, the subject device extract exhibits cytotoxicity from 100.0 % extract concentrations to 50.0 % extract concentrations and no cytotoxicity reactivity from 25.0 % extract concentrations to 3.125 % extract concentrations.
- Acute systemic toxicity: ISO 10993-11 Biological evaluation on medical device Part 11 - Test for systemic toxicity, Under the conditions of this study, the test article did not induce acute systemic toxicity.
- Low Dermatitis Potential: Modified Draize ASTM 6355-07 Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves, There was no clinical evidence that the glove may induce Type IV allergy in the unsensitized general user population.
Clinical data is not needed.
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 logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 8, 2024
Comfort Rubber Gloves Industries Sdn. Bhd. % Terrell Cunningham Regulatory Consultant T. Cunningham Consulting & Associates, LLC 12812 Meadowbrook LN Waldorf, Maryland 20601
Re: K241528
Trade/Device Name: Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA
Dear Terrell Cunningham:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated August 6, 2024. Specifically, FDA is updating this SE Letter to correct a typo in the Regulatory Class as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Bifeng Qian, M.D., Ph.D., OHT4: Office of Surgical and Infection Control Devices, at Bifeng. Qian@fda.hhs.gov.
Sincerely,
Bifeng Qian -S
Bifeng Qian, M.D., Ph.D. Assistant Director DHT4C: Division of Infection Control Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/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 in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
August 6, 2024
Comfort Rubber Gloves Industries Sdn. Bhd. % Terrell Cunningham Regulatory Consultant T. Cunningham Consulting & Associates, LLC 12812 Meadowbrook LN Waldorf, Maryland 20601
Re: K241528
Trade/Device Name: Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class II Product Code: LZA Dated: April 2, 2024 Received: May 30, 2024
Dear Terrell Cunningham:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.
2
Additional information about changes that may requre a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
3
Sincerely,
Allan Guan -S
For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4C: Division of Infection Control Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
4
Indications for Use
Submission Number (if known)
Device Name
Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential
Indications for Use (Describe)
The Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential is a medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between examiner and patient.
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)
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5
510(k) SUMMARY- K241528
Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential
1.0 Submitter:
| Name | Comfort Rubber Gloves Industries Sdn. Bhd. |
|---|---|
| Address | Lot 821, Jalan Matang, |
| 34750 Matang, Perak, Malaysia. | |
| Malaysia. | |
| Phone No. | 605-847 2777 |
| Fax No. | 605-847 9108 |
| Contact Person: | Sumathi d/o Sararavan Sami (Miss.) |
Date of Preparation: 1st August 2024
2.0 Name of the Device
Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential
Common Name: Patient Examination Gloves
Classification Name: Patient Examination Gloves (21 CFR 880.6250)
Class: I
Product Code: LZA
3.0 Predicate Device
Device Name: Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
Company: Hartalega SDN. BHD 510(k) No.: K162646
Common Name: Patient Examination Gloves
Classification Name: Patient Examination Gloves (21 CFR 880.6250)
Class: I
Product Code: LZA
4.0 Description of the Device:
Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential meet ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
6
5.0 Indication for Use of the Device
The Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential is a medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between examiner and patient.
6.0 Summary of the Technological Characteristics of the Device:
Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential and predicate, K162646 are summarized with the following technological characteristics. Both gloves are made with nitrile and meets ASTM D6319-19 - Standard Specification for Nitrile Examination Gloves for Medical Application or equivalent standards.
| CHARACTERISTIC | PREDICATE
DEVICE
K162646 | SUBJECT
DEVICE
K241528 | COMPARISON |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Manufacturer(s) | Hartalega
SDN. BHD | Comfort
Rubber
Gloves
Industries
Sdn. Bhd | Different |
| Device Name | Nitrile Powder
Free
Examination
Glove, Non-
Sterile Low
Dermatitis
Potential (Blue) | Nitrile Powder
Free
Examination
Gloves (Blue),
Non-Sterile
Low
Dermatitis
Potential | Similar |
| Indications for Use | The Nitrile
Powder Free
Examination
Glove, Non-
Sterile Low
Dermatitis
(Blue)
Potential is a
medical glove
which is a
disposable
device
intended for
medical
purposes that
is worn on the
examiner's
hand or finger
to prevent
contamination
between
examiner and
patient. | The Nitrile
Powder Free
Examination
Gloves
(Blue), Non-
Sterile Low
Dermatitis
Potential is a
medical glove
which is a
disposable
device
intended for
medical
purposes that
is worn on the
examiner's
hand or finger
to prevent
contamination
between
examiner and
patient. | Similar |
| Material | Nitrile | Nitrile | Same |
| Color | Blue | Blue | Same |
| CHARACTERISTIC | PREDICATE DEVICE K162646 | SUBJECT DEVICE | COMPARISON |
| Size | XS, S, M, L, XL | XS, S, M, L, XL | Same |
| Dimensions | Meets ASTM D6319-10
Thickness at Finger - min. 0.05mm
Thickness at Palm - min. 0.05mm
Length - Min. 230 mm
Width - M - 95±10mm | Meets ASTM D6319-19
Thickness at Finger - min. 0.05mm
Thickness at Palm - min. 0.05mm
Length - Size XS, S, M, L, XL - Min. 230
Width - XS- 70±10mm S- 80±10mm M- 95±10mm L- | Similar |
| Physical Properties | Meets ASTM D6319-10.
Tensile Strength:
Before Aging
Min. 14 MPa
Ultimate Elongation:
Before Aging
min. 500% | Meets ASTM D6319-19.
Tensile
Before Aging
Min. 14 MPa
Ultimate Elongation
Before Aging
min. 500% | Same |
| | After Aging
Min. 14 MPa
After Aging
min. 400% | After Aging
Min. 14 MPa
After Aging
min. 400% | |
| Powder Content | Meets ASTM 6124-06 (2011)
(≤ 2 mg/glove) | Meets ASTM 6124-06 (2022)
(≤ 2 mg/glove) | Same |
| Freedom from Holes | Meets ASTM D5151-06. | Meets ASTM D5151-19. | Same |
| CHARACTERISTIC | PREDICATE
DEVICE
K162646 | SUBJECT
DEVICE
K241528 | COMPARISON |
| Low Dermatitis
Potential | Meets Modified
Draize ASTM
6355-07
Standard Test
Method for Human
Repeat Insult Patch
Testing of Medical
Gloves. | Meets Modified
Draize ASTM
6355-07
Standard Test
Method for Human
Repeat Insult Patch
Testing of Medical
Gloves. | Same |
| Biocompatibility:
Irritation Tests | Under the conditions
of the study, the
subject device is non-
irritating. | Under the conditions
of the study, the
subject device is non-
irritating. | Same |
| Biocompatibility:
Skin
Sensitization Tests | Under the conditions
of the study, the
subject device is not
sensitizing. | Under the conditions
of the study, the
subject device is not
sensitizing. | Same |
| Biocompatibility:
Cytotoxicity | No test report was
submitted for the
predicate. | Under the conditions
of the study, the
subject device extract
exhibits mild
| Different |
| Biocompatibility:
Acute systemic Toxicity | No test report was
submitted for the
predicate. | Did not induce any
acute systemic toxicity
in swiss albino mice
under the conditions
of the study. | Different |
7
8
9
8.0 Summary of Non-Clinical Performance Data
Non-clinical tests were conducted to demonstrate that the proposed device met all design specifications. The test results demonstrated that the proposed device met the performance criteria with the following standards:
| Test | Standard | Acceptance Criteria | Results |
|---|---|---|---|
| Physical Dimensions | |||
| Thickness | ASTM D6319-19 | ||
| Standard Specification | |||
| for Nitrile Examination | |||
| Gloves for Medical | |||
| Application | ISO 2859-1/S2/AQL 4.0 | ||
| Length - | |||
| Size XS, S, M, L, XL – | |||
| Min. 230 | |||
| Width - | |||
| XS - 70±10mm S – | |||
| 80±10mm | |||
| M – 95±10mm | |||
| L – 110±10mm | |||
| XL – 120±10mm | |||
| Thickness at Finger – | |||
| min. 0.05mm | |||
| Thickness at Palm – | |||
| min. 0.05mm | Pass | ||
| Physical Properties | ASTM D6319-19 | ||
| Standard Specification | |||
| for Nitrile Examination | |||
| Gloves for Medical | |||
| Application | |||
| ASTM D412-16(2021) | |||
| Standard Test Methods | |||
| for Vulcanized Rubber | |||
| and Thermoplastic | |||
| Elastomers-Tension | Before aging: | ||
| Tensile Strength: ≥14 | |||
| MPa | |||
| Ultimate elongation: | |||
| ≥500% | |||
| After aging: | |||
| Tensile Strength: ≥14 | |||
| MPa | |||
| Ultimate elongation: | |||
| ≥400% | Pass | ||
| Powder Residue | ASTM D6124-06(2022) | ||
| Standard Test Method | |||
| for Residual Powder on | |||
| Medical Gloves | ≤ 2 mg/glove | Pass | |
| Freedom from Holes | ASTM D5151-19 | ||
| Standard Test Method | |||
| for Detection of Holes in | |||
| Medical Gloves | AQL 1.5 | Pass | |
| Irritation | ISO 10993-23:2021 | ||
| Biological evaluation of | |||
| medical devices Part 23: | |||
| Tests for irritation | Under the conditions of the | ||
| study, the device is not an | |||
| irritant. | Under the conditions of the | ||
| study, the device was not | |||
| an irritant. | |||
| Sensitization | ISO 10993-10:2021 | ||
| Biological evaluation of | |||
| medical devices Part 10: | |||
| Tests for skin | |||
| sensitization | Under the conditions of the | ||
| study, the device is not a | |||
| sensitizer. | Under the conditions of | ||
| the study, the device | |||
| was not a sensitizer. | |||
| Cytotoxicity | ISO 10993-5 Biological | ||
| evaluation of medical | |||
| devices-Part 5 Tests for | |||
| in vitro cytotoxicity | Under the conditions of | ||
| the study, the subject | |||
| device extract does not | |||
| exhibit cytotoxicity | |||
| reactivity. | Under the conditions of | ||
| the study, the subject | |||
| device extract exhibits | |||
| cytotoxicity from 100.0 % | |||
| extract concentrations to | |||
| 50.0 % extract | |||
| concentrations and | |||
| no cytotoxicity reactivity | |||
| from 25.0 % extract | |||
| concentrations to 3.125 | |||
| % extract | |||
| concentrations. | |||
| Acute systemic toxicity | ISO 10993-11 Biological | ||
| evaluation on medical | |||
| device Part 11 - Test for | |||
| systemic toxicity | Under the conditions of | ||
| this study, the test article | |||
| does not induce acute | |||
| systemic toxicity. | Under the conditions of | ||
| this study, the test article | |||
| did not induce acute | |||
| systemic toxicity. | |||
| Low Dermatitis Potential | Modified Draize | ||
| ASTM 6355-07 | |||
| Standard Test Method | |||
| for Human Repeat Insult | |||
| Patch Testing of Medical | |||
| Gloves. | No clinical evidence that | ||
| the glove may induce | |||
| Type IV allergy in the | |||
| unsensitized general | |||
| user population. | There was no clinical | ||
| evidence that the glove | |||
| may induce Type IV | |||
| allergy in the | |||
| unsensitized general | |||
| user population. |
10
11
9.0 Clinical Performance Data
Clinical data is not needed.
10.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.