(79 days)
Not Found
No
The device description and performance studies focus on the physical properties and safety of a standard examination glove, with no mention of AI or ML.
No
This device is a patient examination glove intended to prevent contamination between patient and examiner, not to treat a medical condition.
No
The device is a non-powdered patient examination glove, intended to prevent contamination between patient and examiner. It is described as a medical device worn on the hand and does not perform any diagnostic function.
No
The device description explicitly states it is a physical glove made from Latex compound, and the performance studies focus on physical and biological properties of the material. There is no mention of software components.
Based on the provided information, 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 purposes that is worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device used for infection control, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description focuses on the physical properties and materials of the glove, not on any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information. The performance studies focus on the physical integrity and biocompatibility of the glove.
Therefore, this device falls under the category of a medical device used for barrier protection, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This non-powdered patient examination glove is a disposable device intended for medical purposes 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)
LYY
Device Description
The subject device in this 510(k) Notification is Iconic Latex Glove - Powder Free Latex Examination Glove. The subject device is a patient examination glove made from Latex compound, Natural White color, powder free and non-sterile (Per 21 CFR 880.6250 - class I). The device meets the specifications in ASTM D3578-19 Standard specification for Rubber Examination Gloves. The available sizes of the subject devices are Small, Medium, Large, X-Larqe.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The device underwent non-clinical testing for conformance with ASTM D3578-19 (Standard Specification for Rubber Examination Gloves for Medical Application), ASTM D5151-19 (Standard Test Method for detection of Holes in Medical Gloves), ASTM D6124-06 (Standard Test Method for Residual Powder on Medical Gloves), ASTM D5712 -15 (Standard Test Method for Analysis of Aqueous Extractable Protein in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method), ISO 10993-5:2009 (Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity), ISO 10993-10:2021 (Biological evaluation on medical device Part 10: Test for Skin Sensitization), ISO 10993-11:2017 (Biological evaluation of medical devices Part 11: Tests for systemic toxicity), and ISO 10993-23:2021 (Biological evaluation of medical devices Part 23: Tests for irritation). Key results include:
- Freedom from hole: Pass (AQL 2.5) for all sizes.
- Dimensions (Length, Width, Thickness - Palm & Fingertip): All sizes passed minimum length (230mm) and width specifications. Thickness at palm and fingertip met the minimum 0.08 mm.
- Physical properties before aging: Tensile Strength, Ultimate Elongation, and Stress at 500% Elongation passed for all sizes.
- Physical properties after accelerated aging: Tensile Strength and Ultimate Elongation passed for all sizes.
- Powder-free Residue: Results were well below the 2.0 mg per glove limit for all sizes.
- Extractable Protein content: All sizes were below the 50 µg/dm2 limit.
- Biocompatibility: Passed tests for Invitro cytotoxicity, irritation and skin sensitization, systemic toxicity, and irritation.
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.
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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.
August 25, 2022
Iconic medicare sdn bhd % A.C. Thirumaran Official Correspondent Integrated Assessment Services Pvt Ltd 1495, Manasarovar, 16th Main road, Anna Nagar West Chennai, Tamil Nadu 600040 India
Re: K221648
Trade/Device Name: Iconic Latex Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LYY Dated: May 20, 2022 Received: June 7, 2022
Dear A.C. Thirumaran:
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 (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.
Bifeng Qian, M.D., 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
2
Indications for Use
510(k) Number (if known) K221648
Device Name Iconic Latex Glove
Indications for Use (Describe)
This non-powdered patient examination glove is a disposable device intended for medical purposes 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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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1.0 Submitter:
Mr. Tan Cho Chia Managing Director Company Name: Iconic Medicare Sdn Bhd. Company Address: PMT 798, LINGKARAN CASSIA SELATAN. TAMAN PERINDUSTRIAN BATU KAWAN, 14110 BANDAR CASSIA, PULAU PINANG. MALAYSIA Email: cctan@iconic.com.my Telephone: 60 4 504159 Date of Summary Prepared: 15th March 2022
2.0 Subject Device Identification:
Trade Name / Proprietary Name: Iconic Latex Glove Device Common Name: Non-powder Patient Examination gloves. Device Classification Name: Natural Rubber Latex Patient Examination gloves Device Classification: 1 Regulation Number: 21 CFR 880.6250 Product Code: LYY
3.0 Official Correspondent
Mr. A.C. Thirumaran Integrated Assessment Services Private Limited No.1495, Manasarovar, 16th Main road, Anna Nagar west, Chennai- 600040, India. Telephone: 91-44-26162670 Email: iasfda16@gmail.com
4.0 Identification of the Legally Marketed Device:
Predicate Device: Careglove Global SDN BHD 510k Number: - K161833 Device Name: Latex Examination Gloves Powder Free Classification Name: Natural Rubber Latex Patient Examination Gloves Device Classification: 1 Regulation Number: 21 CFR 880.6250
5.0 Device Description
The subject device in this 510(k) Notification is Iconic Latex Glove - Powder Free Latex Examination Glove. The subject device is a patient examination glove made from Latex compound, Natural White color, powder free and non-sterile (Per 21 CFR 880.6250 - class I). The device meets the specifications in ASTM D3578-19 Standard specification for Rubber Examination Gloves. The available sizes of the subject devices are Small, Medium, Large, X-Larqe.
6.0 Indications for Use
4
lconic Latex Glove. This non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
7.0 Technological characteristics Comparison for the proposed and predicate devices
The Iconic Latex Glove is a Powder Free Latex Examination Glove, Non-sterile, with the following summarized technological characteristics, in comparison to the Predicate device and specifications in ASTM D3578-19.
| Characteristics | Acceptance Criteria | Subject device:
Iconic Latex Glove
(Small, Medium, Large,
X-Large) | Predicate Device Latex
Examination Gloves
Powder Free Careglove
Global SDN BHD | Comparison
Analysis |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| 510(k) Number | - | K221648 | K161833 | - |
| Product Code | LYY | LYY | LYY | same |
| 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. | This powder free patient
examination glove is a
disposable device
intended for medical
purposes that is worn on
the examiner's hand to
prevent
contamination between
patient and examiner.
The device is for over-
the- counter 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. | same |
| Material used | Latex - Natural
Rubber | Latex - Natural Rubber | Latex - Natural Rubber | same |
| Color | N/A | Natural White | Natural White | same |
| Sterility | Sterile/Non-sterile | Non sterile | Non sterile | same |
| Single use | Single use | Single use | Single use | same |
| | Overall Length
(mm) Min 230mm | Meets ASTM D3578-19 | Meets ASTM D3578-19 | |
| Dimensions | Width (±10mm)
Small - 80
Medium- 95
Large-110
X-large-120 | Meets ASTM D3578-19 | Meets ASTM D3578-19 | same |
| Characteristics | Acceptance Criteria | Subject device:
Iconic Latex Glove
(Small, Medium, Large,
X-Large) | Predicate Device Latex
Examination Gloves
Powder Free Careglove
Global SDN BHD | Comparison
Analysis |
| Physical
Properties | Thickness at Palm
(mm) Min; 0.05 mm | Meets ASTM D3578- 19 | 0.06-0.09mm | same |
| | Thickness at Finger
Tip (mm) Min 0.05
mm | Meets ASTM D3578- 19 | 0.07-0.10mm | |
| Physical
Properties | Before Aging
Tensile Strength =
18 MPa, min.
Ultimate
Elongation = 650
% min Stress at
500 % Elongation
(MPa)
After Accelerated
Aging
Tensile Strength
=14 MPa, min.
Ultimate
Elongation = 500
% min | Meets ASTM D3578- 19 | Meets ASTM D3578- 19 | same |
| Freedom from
pinholes | AQL 2.5 Inspection
Level G-1 | Meets ASTM D5151- 19 | Meets ASTM D5151- 19 | same |
| Residual
Powder |