(127 days)
Not Required
No
The device is a simple examination glove and the summary contains no mention of AI or ML.
No
The device, blue nitrile examination gloves, is intended to prevent contamination between patient and examiner, not to treat or directly manage a medical condition.
No
Explanation: This device, Blue Nitrile Examination Gloves Powder Free, is intended to prevent contamination between patient and examiner and is described as personal protective equipment. It does not perform any diagnostic function.
No
The device is a physical medical device (examination gloves) and does not involve any software component.
Based on the provided information, 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 to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: The description identifies the device as "Class I patient examination gloves." Examination gloves are a common medical device used for protection, not for diagnosing conditions.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide information about a patient's health status through testing performed outside the body.
- Performance Studies: The performance studies focus on the physical properties and safety of the gloves (dimensions, strength, integrity, biocompatibility), which are relevant to their barrier function, not diagnostic accuracy.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
Blue Nitrile Examination Gloves Powder Free is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
Blue Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color and are powder free.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
Indicated 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 device underwent non-clinical testing to demonstrate substantial equivalence to the predicate device. These tests included:
- Length: Tested using ASTM D6319-10 (Reapproved 2015), showing lengths ranging from 245 mm to 248 mm, meeting the minimum 230 mm requirement.
- Width: Tested using ASTM D6319-10 (Reapproved 2015), showing widths meeting the specified ranges for each size.
- Thickness: Tested using ASTM D6319-10 (Reapproved 2015), showing palm and finger thickness of 0.09mm and 0.15mm respectively, exceeding the 0.05 mm minimum.
- Physical Properties (Tensile Strength): Tested using ASTM D6319-10 (Reapproved 2015). Before aging, tensile strength ranged from 18.45Mpa to 18.72Mpa (minimum 14Mpa). After aging, tensile strength ranged from 17.54Mpa to 17.80Mpa (minimum 14Mpa).
- Physical Properties (Ultimate Elongation): Tested using ASTM D6319-10 (Reapproved 2015). Before aging, ultimate elongation ranged from 686% to 705% (minimum 500%). After aging, ultimate elongation ranged from 659% to 674% (minimum 400%).
- Water Tightness: Tested using ASTM D5151-06 (Reapproved 2015), demonstrating that the gloves pass AQL 1.5 for holes.
- Powder Residue: Tested using ASTM D6124-06 (Reapproved 2017), with results ranging from 0.21mg/glove to 0.22 mg/glove, well within the 2 Mg/Glove Max acceptance criteria.
- Biocompatibility (Primary Skin Irritation): Tested using ISO 10993-10:2010(E), concluding that the device is not an irritant.
- Biocompatibility (Dermal Sensitization): Tested using ISO 10993-10:2010(E), concluding that the device is not a sensitizer.
- Biocompatibility (In vitro cytotoxicity): Tested using ISO10993-5:2009(E), concluding that under the conditions of the study, the device is cytotoxic.
- Biocompatibility (Acute Systemic Toxicity): Tested using ISO 10993-11:2017(E), concluding that the device extracts do not pose a systemic toxicity concern.
- Biocompatibility (Material Mediated Pyrogenicity): Tested using ISO 10993-11:2017(E) / USP 41, concluding that the device did not demonstrate a material mediated pyrogenicity response.
- Biocompatibility (Bacterial Endotoxin test): Tested using USP 42, showing results of
§ 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 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 in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
September 16, 2021
Aspen Glove Sdn. Bhd. % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE 114 Aurora, Illinois 60504
Re: K211479
Trade/Device Name: Blue Nitrile Examination Glove Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: August 16, 2021 Received: August 16, 2021
Dear Manoj Zacharias:
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 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,
For 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) K211479
Device Name
Blue Nitrile Examination Glove Powder Free
Indications for Use (Describe)
Blue Nitrile Examination Gloves Powder Free is disposable device intended for medical purpose that is worn on the examiner's hand 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)
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510(K) SUMMARY K211479 As required by: 21CFR§807.92(c)
A. APPLICANT INFORMATION
| 510(K) Owner's Name | Aspen Glove Sdn. Bhd. |
|---|---|
| Address | Aspen House, 300, JLN Macalister, |
| 10450 Georgetown, Pulau Pinang, | |
| Malaysia | |
| Phone | +604- 227 5000 |
| Fax | +604- 227 5000 |
| corporate@aspen.com.my | |
| Contact Person | Mr. Iskandar Basha bin Abdul Kadir |
| Designation | Managing Director |
| Contact Number | 017-550 0577 |
| Contact Email | Iskandar@aspenglove.com.my |
| Date Submitted | 16 September 2021 |
B. DEVICE IDENTIFICATION
| Name of the device | Blue Nitrile Examination Glove Powder Free |
|---|---|
| Product proprietary or trade name | AspenMed+ |
| Common or usual name | Exam Gloves |
| Classification name | Patient Examination Gloves |
| Device Classification | Class-I |
| Product Code | LZA |
| Regulation Number | 21 CFR 880.6250 |
| Review Panel | General Hospital |
C. PREDICATE DEVICE
| Predicate Device | JR Engineering & Medical Technologies (M) SDN.BHD |
|---|---|
| 510( K) Number | K192333 |
| Regulatory Class | I |
| Product code | LZA |
D. DESCRIPTION OF THEDEVICE:
Blue Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color and are powder free.
E. INTENDED USE OF THE DEVICE:
Blue Nitrile Examination Gloves Powder Free is disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.
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F. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
| Characteristics | Standards | Device Performance | Remarks | |
|---|---|---|---|---|
| Predicate | Subject | |||
| 510(K) Number | K192333 | K211479 | --- | |
| Name of device | JR MEDIC Blue Nitrile | |||
| Examination Gloves | ||||
| Powder-free | Blue Nitrile | |||
| Examination Gloves | ||||
| Powder Free | --- | |||
| Dimensions | ASTMD6319-10 | |||
| (Reapproved 2015) | Length Min 230 m Width | |||
| Min 95+/-10 | ||||
| mm(for medium size) | Length Min 230 mm | |||
| Width Min 95+/-10 | ||||
| mm(for medium size) | Same | |||
| Physical Properties | ASTMD6319-10 | |||
| (Reapproved 2015) | Before Aging | |||
| Tensile Strength | ||||
| min 14 Mpa | ||||
| Ultimate Elongation | ||||
| Min 500% | ||||
| After Aging | ||||
| Tensile Strength | ||||
| min 14 Mpa | ||||
| Ultimate Elongation | ||||
| Min 400% | Before Aging | |||
| Tensile Strength min | ||||
| 14 Mpa | ||||
| Ultimate Elongation | ||||
| Min 500% | ||||
| After Aging | ||||
| Tensile Strength | ||||
| min 14 Mpa | ||||
| Ultimate Elongation | ||||
| Min 400% | Same | |||
| Thickness | ASTMD6319-10 | |||
| (Reapproved 2015) | Palm min 0.05 mm | |||
| Finger min 0.05 mm | Palm min 0.05 mm | |||
| Finger min 0.05 mm | Same | |||
| Powder Residue | ASTMD6319-10 | ≤2 mg/glove | ≤2 mg/glove | Similar |
| Biocompatibility | Primary Skin | |||
| Irritation- | ||||
| ISO 10993- | ||||
| 10:2010(E) | Under the condition of | |||
| study not an irritant | Under the condition | |||
| of study not an | ||||
| irritant | Same | |||
| Dermal | ||||
| Sensitization- ISO | ||||
| 10993-10:2010( E) | Under the conditions of | |||
| the study not a sensitizer | Under the conditions | |||
| of the study not a | ||||
| sensitizer | Same | |||
| In vitro cytotoxicity | ||||
| ISO10993-5 | ||||
| :2009(E) | Under the conditions | |||
| of the study, cytotoxic | Under the conditions | |||
| of the study, | ||||
| cytotoxic | Same | |||
| Acute Systemic | ||||
| Toxicity Test ISO | ||||
| 10993-11:2017(E) | Under the conditions | |||
| of study the device | ||||
| extracts do not pose a | ||||
| systemic toxicity concern | Under the conditions | |||
| of study the device | ||||
| extracts do not pose a | ||||
| systemic toxicity | ||||
| concern | Same | |||
| Material Mediated | ||||
| Pyrogenicity ISO | ||||
| 10993-11:2017(E) / | ||||
| USP 41 | Under the conditions of | |||
| the study non pyrogenic | Under the conditions | |||
| of the study non | ||||
| pyrogenic | Same | |||
| Bacterial Endotoxin | ||||
| test USP 42 | No data available | To determine the pyrogenic | ||
| potential of the test item | ||||
| extract following intravenous | ||||
| injection in New Zealand | ||||
| white Rabbits. | Under the | |||
| conditions of the | ||||
| study, the device | ||||
| did not | ||||
| demonstrate a | ||||
| material mediated | ||||
| pyrogenicity | ||||
| response. | Under the conditions of | |||
| the study, the device did | ||||
| not demonstrate a | ||||
| material mediated | ||||
| pyrogenicity response. | ||||
| Bacterial Endotoxin test | ||||
| USP 42 | To determine the Bacterial | |||
| Endotoxin limit in the glove | NMT 20 EU/pair of | |||
| gloves |