(129 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a standard examination glove, with no mention of AI or ML.
No.
The device (patient examination glove) is intended to prevent contamination between patient and examiner, not to treat or diagnose a medical condition.
No
Explanation: The device is described as a glove worn on the hand or finger to prevent contamination, which is a barrier device, not one that gathers or interprets data for diagnosis.
No
The device is a physical examination glove made of Nitrile rubber, which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between patient and examiner by being worn on the hand or finger. This is a barrier function, not a diagnostic one.
- Device Description: The description focuses on the physical properties and manufacturing of a glove for protection. There is no mention of analyzing samples, detecting substances, or providing diagnostic information.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This glove does not perform any of these functions.
- Predicate Device: The predicate device is also a disposable examination glove, which is a Class I medical device, not an IVD.
Therefore, this device is a medical device intended for barrier protection, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
A patient examination glove is a disposable device made of Nitrile rubber 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 Nitrile Examination Glove - Black, Non-Sterile meet all requirements of ASTM standard D6319 and FDA 21 CFR 880.6250.
The powder free nitrile examination glove is manufactured from Nitrile rubber. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the qloves without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand and it is a single use device.
Design: Ambidextrous (i.e., fit either hand)
Finish: Texture Finger
Performance: See Section 7 Summary of Non-Clinical Testing.
Storage: The product is kept away from direct sun and fluorescent lighting and stored in an environment with temperature not exceeding 40-degree C.
Information For "Powder Free" Claim: The finished powder free gloves meet ASTM D6319 requirements and are tested in according to ASTM D6124 method for powder measurement (less than 2mg per glove).
Glove Size and dimension: Measurement is done as per ASTM D6319. Length is measured from the tip of the middle finger to the outside edge of the cuff. Width is measured at a level between the base of the index finger and the base of the thumb.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger
Indिकेटेड Patient Age Range
Not Found
Intended User / Care Setting
examiner
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)
The performance test data of the non-clinical test for this powder free nitrile examination glove is summarized as per below.
Physical Properties
- Test Method: ASTM D412 (Standard Test Method for Vulcanized Rubber and Thermoplastic Elastomers-Tension)
- Purpose of Testing: To evaluate the tensile (tension) properties of glove.
- Acceptance Criteria (Before aging): Tensile strength Min 14.0 MPa; Ultimate elongation Min 500%
- Acceptance Criteria (After aging): Tensile strength Min 14.0 MPa; Ultimate elongation Min 400%
- Results (Before aging): 29.7Mpa; 585%
- Results (After aging): 33.1Mpa; 554%
- Status: Pass
Dimension
- Test Method: ASTM D3767 Standard Practice for Rubber—Measurement of Dimensions
- Purpose of Testing: To measure the length, width and thickness of glove
- Glove Size: X-Small
- Acceptance Criteria: Length Min 240 mm; Width 70 ± 10 mm; Thickness Finger - min 0.05mm; Palm - min 0.05mm
- Results: Length 250 mm; Width 78.0 mm; Thickness 0.10 mm; 0.07 mm
- Status: Pass
- Glove Size: Small
- Acceptance Criteria: Length Min 240 mm; Width 80 ± 10 mm; Thickness Finger - min 0.05mm; Palm - min 0.05mm
- Results: Length 250 mm; Width 88.0 mm; Thickness 0.10 mm; 0.07 mm
- Status: Pass
- Glove Size: Medium
- Acceptance Criteria: Length Min 240 mm; Width 95 ± 10 mm; Thickness Finger - min 0.05mm; Palm - min 0.05mm
- Results: Length 250 mm; Width 98.0 mm; Thickness 0.10 mm; 0.07 mm
- Status: Pass
- Glove Size: Large
- Acceptance Criteria: Length Min 240 mm; Width 110 ± 10 mm; Thickness Finger – min 0.05mm; Palm - min 0.05mm
- Results: Length 249 mm; Width 108 mm; Thickness 0.10 mm; 0.07 mm
- Status: Pass
- Glove Size: X-Large
- Acceptance Criteria: Length Min 240 mm; Width 120 ± 10 mm; Thickness Finger – min 0.05mm; Palm - min 0.05mm
- Results: Length 250 mm; Width 118 mm; Thickness 0.10 mm; 0.07 mm
- Status: Pass
Watertight
- Test Method: ASTM D5151 (Standard Test Method for Detection of Holes in Medical Gloves)
- Purpose of Testing: To detect holes that leak water and thereby compromise the usefulness of the glove.
- Acceptance Criteria: Sample size: 500 pcs; Inspection level: G1; AQL: 1.5, Acceptance No. 10
- Results: The batch size for this sampling is 150,001 to 500,000. Hence, according to the single sampling plan GI, the sample to be drawn is under code M equivalent to 315 pieces with accept 10 and reject 11 to be accepted under AQL 1.5. During the test, 0 piece was found with leaks. Hence it falls within the acceptance criteria.
- Status: Pass
Residual Powder
- Test Method: ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves)
- Purpose of Testing: To determine the amount of residual powder and non-powder solids found on gloves.
- Acceptance Criteria: Less than 2 mg per glove
- Results: Sample size : 5 pcs; Requirement :
§ 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.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is 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.
January 9, 2022
Hong Seng Gloves Sdn Bhd % Michael Van Der Woude U.S. Agent Emergo Global Representative LLC 2500 Bee Cave Road, Building 1 Suite 300 Austin, Texas 78746
Re: K212801
Trade/Device Name: Powder free nitrile examination glove- black, non sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA Dated: December 2, 2021 Received: December 7, 2021
Dear Michael Van Der Woude:
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,
Clarence W. Murray III, Ph.D. Assistant Director 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
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Indications for Use
510(k) Number (if known) K212801
Device Name POWDER FREE NITRILE EXAMINATION GLOVE - BLACK, NON STERILE
Indications for Use (Describe)
A patient examination glove is a disposable device made of Nitrile rubber 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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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1.0 Sponsor:
2.0
| Company Name: | Hong Seng Gloves Sdn Bhd |
|---|---|
| Company Address: | Lot 97, Jalan 10, Kawasan Perusahaan Bakar Arang, 08000 |
| Sungai Petani, Kedah, Malaysia. | |
| Submitter: | |
| Contact Person: | Mr. Ho Chia Yao |
| Company Name: | Hong Seng Gloves Sdn Bhd |
| Company Address: | Lot 97, Jalan 10, Kawasan Perusahaan Bakar Arang, 08000 |
| Sungai Petani, Kedah, Malaysia. | |
| Phone No.: | +604-4211555 |
| Fax No.: | +604-4211555 |
Date of Summary Prepared: 20th July 2021 (revised on 8th January 2022)
3.0 Identification of the subject device:
| Trade Name | : Powder Free Nitrile Examination Glove - Black, Non- Sterile |
|---|---|
| Common Name | : Patient Examination Gloves |
| Classification Name | : Patient Examination Gloves |
| Device Classification | : 1 |
| Regulation Number | : 21 CFR 880.6250 |
| Product Code | : LZA. |
3.0 Predicate Device:
K190942
Disposable Powder Free Nitrile Examination Glove, Black Color Company: Ever Growth (Vietnam) Co. Ltd.
4.0 Description of The Device:
Powder Free Nitrile Examination Glove - Black, Non-Sterile meet all requirements of ASTM standard D6319 and FDA 21 CFR 880.6250.
The powder free nitrile examination glove is manufactured from Nitrile rubber. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the qloves without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand and it is a single use device.
| Design | : Ambidextrous (i.e., fit either hand) |
|---|---|
| Finish | : Texture Finger |
| Performance | : See Section 7 Summary of Non-Clinical Testing. |
Storage:
The product is kept away from direct sun and fluorescent lighting and stored in an environment with temperature not exceeding 40-degree C.
4
Information For "Powder Free" Claim:
The finished powder free gloves meet ASTM D6319 requirements and are tested in according to ASTM D6124 method for powder measurement (less than 2mg per glove).
Glove Size and dimension:
Measurement is done as per ASTM D6319. Length is measured from the tip of the middle finger to the outside edge of the cuff. Width is measured at a level between the base of the index finger and the base of the thumb.
| Size | Palm Width (mm) | Length (mm) |
|---|---|---|
| X-Small | 70±10 | Minimum 230 |
| Small | 80±10 | Minimum 230 |
| Medium | 95±10 | Minimum 230 |
| Large | 110±10 | Minimum 230 |
| X-Large | 120±10 | Minimum 230 |
5.0 Indication for use:
A patient examination glove is a disposable device made of Nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
6.0 Technological Characteristics Comparison of the Device:
Provided below is the technological comparison of the subject device vs the predicate device as shown in Table 1.
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Table 1
| DEVICE PERFORMANCE | ||||
|---|---|---|---|---|
| CHARACTERIST | ||||
| ICS | STANDARDS | PREDICATE | SUBJECT DEVICE | COMPARISON |
| ANALYSIS | ||||
| BLACK | BLACK | |||
| 510(k) Number | - | K190942 | K212801 | |
| Manufacturer(s) | - | Ever Growth Enterprise | ||
| Corporation | Hong Seng Gloves Sdn Bhd | Same | ||
| Material | ASTM D6319 | Nitrile | Nitrile | Same |
| Color | - | Black | Black | Same |
| Physical | ||||
| Properties | ASTM D6319 | |||
| Before Aging | ||||
| Tensile Strength: | ||||
| Ultimate | ||||
| Elongation: | 14Mpa, min | |||
| 500% min | 29.7Mpa | |||
| 585% | Different but | |||
| within the ASTM | ||||
| standard | ||||
| After Aging | ||||
| Tensile Strength: | ||||
| Ultimate | ||||
| Elongation: | 14Mpa, min | |||
| 400% min | 33.1Mpa | |||
| 554% | Different but | |||
| within the ASTM | ||||
| standard | ||||
| Physical | ||||
| Dimensions: | ||||
| Glove Length: | Complies with ASTM D6319 - | |||
| 230mm minimum | Complies with ASTM D 6319 - | |||
| 230mm minimum. | Similar | |||
| Glove | ||||
| Thickness: |
- Finger
- Palm | ASTM D6319 | 0.05mm min
0.05mm min | 0.10mm
0.07mm | Different but
within the ASTM
standard |
| Glove Palm
Width:
X-Small
Small
Medium
Large
X-Large | | Complies with ASTM D6319 | Complies with ASTM D6319 | Similar |
| Powder Free | ASTM D6124 |