(133 days)
Not Found
No
The device is a physical examination glove and the summary focuses on its physical and barrier properties, with no mention of AI/ML.
No.
The device is described as a glove intended to prevent contamination between patient and examiner, which is a barrier function, not a therapeutic one.
No
Explanation: The device is described as a "patient examination glove" intended to "prevent contamination between patient and examiner." Its function is barrier protection, not the diagnosis of a disease or condition. The performance studies and key metrics listed relate to the physical properties and safety of the glove (e.g., freedom from holes, dimensions, strength, irritation), not diagnostic accuracy.
No
The device is a physical examination glove, which is a hardware medical device, not software. The description focuses on physical properties and performance testing of the glove material.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is "worn on the examiner's hand or finger to prevent contamination between patient and examiner." This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the physical properties and barrier function of the glove, referencing standards related to glove performance and safety (ASTM, ISO). It does not mention any reagents, assays, or procedures for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
- Performance Studies: The performance studies focus on the physical integrity, barrier properties, and biocompatibility of the glove, not on diagnostic accuracy or analytical performance.
In summary, the device is a medical glove intended for barrier protection, not for performing diagnostic tests on samples.
N/A
Intended Use / Indications for Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
Powder Free Blue Nitrile Examination Glove meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed Device complies with the following standards:
- ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
- . ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- ASTM D6124-06,Standard Test Method for Residual Powder on Medical Gloves .
- ASTM D5151-06, Standard Test Method for Detection of Holes in Medical Gloves. ●
- . ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application
- ISO 2859-1:1999, "Sampling Procedures for Inspection by Attributes Part I: Sampling Plans ● Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection.
Test Method: ASTM D6124, Purpose: To check the amount of powder residue from glove surface, Acceptance Criteria: Less than 2mg/glove, Results: Pass
Test Method: ASTM D5151, Purpose: To detect the presence of hole in glove, Acceptance Criteria: Meet AQL 2.5 from sampling of the lot, Results: Pass
Test Method: ASTM D6319, Purpose: To measure the following physical parameters of the glove a) Length b) Palm Thickness c) Tensile Strength before age d) Tensile Strength after age e) Elongation before age f) Elongation after age, Acceptance Criteria: a) Length at minimum 230mm b) Palm Thickness at minimum 0.05mm c) Tensile strength before age at minimum 14MPa d) Tensile Strength after age at minimum 14MPa e) Elongation before age at minimum 500% f) Elongation after age at minimum 400%, Results: Pass
Test Method: ISO 10993, Purpose: To determine the irritation potential of glove when expose to skin surface and also to evaluate whether residual chemical additives at the level that may induce Type IV allergy a) Primary Skin Irritation Test b) Skin Sensitization Test, Acceptance Criteria: a) Not an Irritant b) Not a Sensitizer, Results: Pass
Test Method: ISO 10993-11, Purpose: To evaluate the human hazard potential from glove, Acceptance Criteria: a) Not induce systemic toxicity, Results: Pass
No clinical test is included in this submission.
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
June 21, 2021
Duramitt sdn Bhd Terence Lim RA Specialist No. 3, Jalen Baling Padong Meha Industrial Estate Padang Serai Kulim, Kedah 09400 Malaysia
Re: K210375
Trade/Device Name: Powder Free Blue Nitrile Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: May 16, 2021 Received: May 24, 2021
Dear Terence Lim:
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
1
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 (QS) 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,
Ryan Ortega, PhD Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K210375
Device Name
门 Powder Free Blue Nitrile Examination Glove
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (9/13)
3
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4
No. 3, Jalan Baling, Padong Meha Industrial Estate, Padang Serai, Kulim 09400, Kedah, Malaysia
Attachment 3
510 (K) SUMMARY SHEETS
1.0
510 (K) SUMMARY
| 2.0 Submitter | Duramitt Sdn Bhd | |
|---|---|---|
| No. 3, Jalan Baling, Padong Meha Industrial Estate | ||
| Padang Serai, Kulim 09400, Kedah, Malaysia | ||
| Tel: | +60-3-87668191 | |
| Fax: | +60-3-87668191 | |
| Name of Contact Person: | Terence Lim | |
| Email Address: | limsinkooi@gmail.com | |
| Date of Summary Prepared: | January 17, 2021 |
3.0 Name of Device:
| 510(k) number | K210375 |
|---|---|
| Trade Name: | Powder Free Blue Nitrile Examination Glove |
| Classification Name: | Polymer Patient Examination Glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital |
| Product Code: | LZA |
4.0 Identification of The Legally Marketed Device
Predicate Device Name: Powder Free Blue Nitrile Examination Glove
Predicate 510(K) Number: K153562
Manufacturer's Name: VIETGLOVE CORPORATION
5.0 Description of Device
Powder Free Blue Nitrile Examination Glove meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.
6.0 The Intended Use of Glove
A patient 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
7.0 Summary of the Technological Characteristic of the Device compared to the Predicate Device for Substantial Equivalent Discussion.
There is no difference in technology characteristic compared to the predicate device. Gloves are made from nitrile latex compound. Non-Sterile, Powder Free Blue Nitrile Examination Gloves has the below technological characteristic compared to ASTM or Equivalent standards.
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No. 3, Jalan Baling, Padong Meha Industrial Estate, Padang Serai, Kulim 09400, Kedah, Malaysia
Comparison between Proposed Device & Predicate Device
| Characteristics and
Parameters | Proposed Device -
Powder Free Nitrile
Examination Gloves
(K210375) | Predicate Device -
Powder Free Blue
Nitrile Examination
Gloves (K153562 ) | Discussion |
|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|
| Product Code | LZA | LZA | Same product Code |
| Intended Use | A patient examination
glove is a disposable
device intended for
medical purposes that
is worn on the hand or
finger to prevent
contamination between
patient and examiner. | A patient examination
glove is a disposable
device intended for
medical purposes that
is worn on the hand or
finger to prevent
contamination
between patient and
examiner. | Same Intended Use. |
| Classification | Class 1 | Class 1: | Same Class. |
| Raw Rubber Material | Nitrile (Acrylonitrile-
butadiene) | Nitrile (Acrylonitrile-
butadiene) | Same synthetic rubber
material. |
| Surface Appearance | 1.Blue
2. Ambidextrous
3.Finger Textured | 1.Blue
2. Ambidextrous
3.Finger Textured | Same color, ambidextrous
design and same texture
area. |
| Freedom of Holes
Meet AQL 2.5 at G1 | Meet AQL 1.5 with
G1 | Meet AQL 1.5 with
G1. | Similar |
| Overall Length
Minimum 230mm | Average :
S : 242 mm
M : 242 mm
L : 243 mm | More than 230mm | Similar |
| Width
S : 75mm - 95mm
M: 85mm – 105mm
L: 100mm – 120mm | Average :
S : 84 mm
M : 96 mm
L : 107 mm | Meeting
specification | Similar |
| Palm Thickness
(Minimum 0.05mm) | Average :
S : 0.06 mm
M : 0.06 mm
L : 0.06 mm | More than 0.05mm | Similar |
| Finger Thickness
(Minimum 0.05mm) | Average :
S : 0.08 mm
M : 0.08 mm
L : 0.08 mm | More than 0.05mm | Similar |
| Tensile Strength
(before age)
Minimum 14 MPa | Average :
S : 19.37 MPa
M : 19.04 MPa
L : 19.81 MPa | More than 14 MPa | Similar |
| Tensile Strength
(After Age)
Minimum 14 MPa | Average :
S : 84 mm
M: 94mm
L 103mm | More than 14 MPa | Similar |
| Characteristics and
Parameters | Proposed Device -
Powder Free Nitrile
Examination Gloves
(K210375) | Predicate Device -
Powder Free Blue
Nitrile Examination
Gloves (K153562 ) | Discussion |
| Ultimate Elongation
before age
(Minimum 500%) | Average :
S : 560%
M : 560%
L : 560% | Minimum 500% | Similar |
| Ultimate Elongation
after age
(Minimum 400%) | Average :
S : 500%
M: 510%
L : 510% | Minimum 400% | Similar |
| Residual powder test
(Less than
2mg/glove) | Average powder
residue for each size:
S : 0.61 mg/glove
M : 0.59 mg/glove
L : 0.57 mg/glove | Contained less than
2mg/glove | Similar |
| Primary Skin Irritation | Under the conditions
of study, not an
irritant | Under the conditions
of study, not an
irritant | Similar |
| Dermal Sensitization | Under the conditions
of study, not a
sensitizer. | Under the conditions
of study, not a
sensitizer. | Similar |
| Acute Systemic
Toxicity | Not induce systemic
toxicity | Not done | Meeting the requirements
per ISO 10993-11 |
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No. 3, Jalan Baling, Padong Meha Industrial Estate, Padang Serai, Kulim 09400, Kedah, Malaysia
Non-Clinical Test Conclusion
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed
Device complies with the following standards:
- ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
- . ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- ASTM D6124-06,Standard Test Method for Residual Powder on Medical Gloves .
- ASTM D5151-06, Standard Test Method for Detection of Holes in Medical Gloves. ●
- . ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application
- ISO 2859-1:1999, "Sampling Procedures for Inspection by Attributes Part I: Sampling Plans ● Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection.
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No. 3, Jalan Baling, Padong Meha Industrial Estate, Padang Serai, Kulim 09400, Kedah, Malaysia
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6124 | To check the amount of powder | ||
| residue from glove surface | Less than 2mg/glove | Pass | |
| ASTM D5151 | To detect the presence of hole in | ||
| glove | Meet AQL 2.5 from sampling of | ||
| the lot | Pass | ||
| ASTM D6319 | To measure the following physical | ||
| parameters of the glove | |||
| a) Length | |||
| b) Palm Thickness | |||
| c) Tensile Strength before age | |||
| d) Tensile Strength after age | |||
| e) Elongation before age | |||
| f) Elongation after age | a) Length at minimum 230mm | ||
| b) Palm Thickness at minimum | |||
| 0.05mm | |||
| c) Tensile strength before age | |||
| at minimum 14MPa | |||
| d) Tensile Strength after age at | |||
| minimum 14MPa | |||
| e) Elongation before age at | |||
| minimum 500% | |||
| f) Elongation after age at | |||
| minimum 400% | Pass | ||
| ISO 10993 | To determine the irritation potential | ||
| of glove when expose to skin | |||
| surface and also to evaluate | |||
| whether residual chemical additives | |||
| at the level that may induce Type IV | |||
| allergy | |||
| a) Primary Skin Irritation Test | |||
| b) Skin Sensitization Test | a) Not an Irritant | ||
| b) Not a Sensitizer | Pass | ||
| ISO 10993-11 | To evaluate the human hazard | ||
| potential from glove | a) Not induce systemic toxicity | Pass |
Clinical Test Conclusion
No clinical test is included in this submission.
Conclusion
The conclusion drawn from the nonclinical tests demonstrates the subject device in 510(K) submission K210375, Powder Free Nitrile Examination Glove is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K153562.