(251 days)
Not Found
No
The device description and performance data focus on the physical properties and barrier function of examination gloves, with no mention of AI or ML technologies.
No.
The device's intended use is to "prevent contamination between patient and examiner," which is a protective function, not a therapeutic one. It does not treat or cure any medical condition.
No
Explanation: The device is a patient examination glove, explicitly stated as preventing contamination between patient and examiner. Its function is barrier protection, not the diagnosis of any condition or disease.
No
The device is a physical examination glove, which is a hardware device, 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 clearly stated as a "disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used externally.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device does not involve testing samples from the body.
- Device Description: The description focuses on the physical properties and barrier function of the glove, not on any diagnostic testing mechanism.
- Lack of IVD-related information: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, this device is a medical device, specifically a patient examination glove, but it does not fit the definition of an In Vitro Diagnostic.
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)
LYY
Device Description
Powder Free Latex Examination Gloves meets all the current specifications listed under the ASTM Specification D3578-05, Standard Specification for Rubber Examination Gloves. 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 / Medical purposes
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 tests is reported in the table above. From the non-clinical tests, it can be concluded that the Powder Free Latex Examination Glove, Non-Sterile, is as safe and as effective and performs as well or better than the legally marketed preeicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Overall Length Minimum 230mm: Average: 242 mm
- Width: Average: S: 85 mm, M: 95mm, L:104mm
- Palm Thickness (Minimum 0.08mm): Average: 0.09mm
- Finger Thickness (Minimum 0.08mm): Average: 0.11 mm
- Tensile Strength (before age) Minimum 18 MPa: Average: 23.65 MPa
- Tensile Strength (After Age) Minimum 14 MPa: Average: 20.99 MPa
- Stress at 500% Elongation 5.5 MPa Maximum: 3.5 MPa
- Ultimate Elongation before age (Minimum 500%): Average: 734%
- Elongation Ultimate after age (Minimum 400%): Average: 622%
- Freedom of Holes Meet AQL 2.5 at G1: Meet AQL 2.5 with G1
- Residual powder test (Less than 2mg/glove): Average powder residue for each size: S: 0.43 mg/glove, M 0.31 mg/glove, L 0.47 mg/glove
- Protein Testing: S size: Less than 50 µg/dm², M size: Less than 50 µg/dm², L size: Less than 50 µg/dm²
- Primary Skin Irritation: Under the conditions of study, not an irritant
- Dermal Sensitization: Under the conditions of study, not a sensitizer.
- Cytotoxicity: Under the condition of the study, the extract from the device is non- cytotoxic to L- 929 cells
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). 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.
June 6, 2018
Professional Latex Sdn Bhd Terence Lim Regulatory Affairs Manager Lot 52, Jalan Logam 2, Kamunting Raya Industrial Kamunting, Perak 34600 Malaysia
Re: K173053
Trade/Device Name: Powder Free Latex Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LYY Dated: April 30, 2018 Received: May 7, 2018
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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
Page 2 - Terence Lim
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Geeta K. Pamidimukkala -S for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173053
Device Name Powder Free Latex 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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Professional Latex Sdn Bhd
Lot 52, Jalan Logam 2, Kamunting Raya Industrial, 34600 Kamunting, Perak
510 (K) SUMMARY
| 1.0 | Submitter | Professional Latex Sdn Bhd
Lot 52, Jalan Logam 2, Kamunting Raya Industrial
34600 Kamunting, Perak |
|-----|---------------------------|----------------------------------------------------------------------------------------------------------|
| | Tel: | +605 - 891 1637 |
| | Fax: | +605 - 891 1417 |
| | Name of Contact Person: | Terence Lim |
| | Email Address: | Terencelim @professionallatex.com |
| | Date of Summary Prepared: | May 31, 2018 |
2.0 Name of Device:
| 510k no. | K173053 |
|---|---|
| Trade Name: | Powder Free Latex Examination Glove |
| Classification Name: | Non-Powder Patient Examination Glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital |
| Product Code: | LYY |
3.0 Identification of The Legally Marketed Device
Predicate Device Name: LATEX EXAMINATION GLOVES POWDER FREE
Predicate 510(K) Number: K161833
Manufacturer's Name: CAREGLOVE GLOBAL SDN BHD
4.0 Description of Device
Powder Free Latex Examination Gloves meets all the current specifications listed under the ASTM Specification D3578-05, Standard Specification for Rubber Examination Gloves. 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.
5.0 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
4
Lot 52, Jalan Logam 2, Kamunting Raya Industrial, 34600 Kamunting, Perak
Summary of the Technological Characteristic of the Device compared to the Predicate Device 6.0 for Substantial Equivalent Discussion.
There is no difference in technology characteristic compared to the predicate device. Gloves are made from natural rubber latex compound. Non-Sterile, Powder Free Latex Examination Gloves has the below technological characteristic compared to ASTM or Equivalent standards.
| Characteristics
and Parameters | Powder Free Latex
Examination Glove
(K173053) | Powder Free Latex
Examination Glove
(K161833) | Comparison |
|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Product Code | LYY | LYY | 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.
Meeting 21 CFR
880.6250
requirement. |
| Classification | Class 1 | Class 1: | Same. |
| Raw Rubber
Material | Natural Rubber Latex | Natural Rubber Latex | Same base material. |
| Colour | No colour pigment
added. Natural White | No colour pigment
added.Natural White | Similar. |
| Overall Length
Minimum 230mm | Average: 242 mm | Meet ASTM D3578-05 | Similar.
Meeting requirement
of length under ASTM
D 3578-05 |
| Width | Average:
S: 85 mm
M: 95mm
L:104mm: | S: 82mm – 87 mm
M: 94mm – 97 mm
L: 102mm – 107mm | Similar.
Meeting requirement
of Width under ASTM
D 3578-05 |
| Palm Thickness
(Minimum 0.08mm) | Average:
0.09mm | 0.12mm - 0.14 mm | Similar.
Meeting requirement
of Palm thickness
under ASTM D 3578-
05 |
| Finger Thickness
(Minimum 0.08mm) | Average:
0.11 mm | 0.10 - 0.13 mm | Similar.
Meeting requirement
of Palm thickness
under ASTM D 3578-
05 |
| Characteristics and
Parameters | Powder Free Latex
Examination Glove
(K173053) | Powder Free Latex
Examination Glove
(K161833) | Comparison |
| Tensile Strength
(before age)
Minimum 18 MPa | Average: 23.65 MPa | 21.18 – 26.17 MPa | Similar.
Meeting requirement
of Tensile Strength
under ASTM D 3578-
05 |
| Tensile Strength
(After Age)
Minimum 14 MPa | Average: 20.99 MPa | 18.28 – 23.88 MPa | Similar.
Meeting requirement
of Tensile Strength
under ASTM D 3578-
05 |
| Stress at 500%
Elongation
5.5 MPa Maximum | 3.5 MPa | 3.0 – 4.2 MPa | Similar.
Meeting requirement
of Tensile Strength
under ASTM D 3578-
05 |
| Ultimate Elongation
before age
(Minimum 500%) | Average: 734% | 750.20% - 820.20% | Similar.
Meeting requirement
of Tensile Strength
under ASTM D 3578-
05 |
| Elongation
Ultimate
after age
(Minimum 400%) | Average: 622% | 550.40% - 700.50% | Similar.
Meeting requirement
of Tensile Strength
under ASTM D 3578-
05 |
| Freedom of Holes
Meet AQL 2.5 at G1 | Meet AQL 2.5 with G1 | Meet AQL 2.5 with
G1. | Similar.
Meeting requirements
of Freedom of Holes
under ASTM D 3578-
05 |
| Residual powder test
(Less than
2mg/glove) | Average powder
residue for each size:
S: 0.43 mg/glove
M 0.31 mg/glove
L 0.47 mg/glove | Contained less than
2mg/glove | Similar.
Meeting requirement
of powder residue
under ASTM D 3578-
05 |
| Protein Testing | S size: Less than 50
µg/dm²
M size: Less than 50
µg/dm²
L size: Less than 50
µg/dm² | less than 50 µg/dm² | Similar.
Meeting requirement
of protein level under
ASTM D 3578-05 |
| Primary Skin
Irritation | Under the conditions
of study, not an
irritant | Under the conditions
of study, not an
irritant | Same.
Both are tested to be
non-irritant. Under
ISO 10993 -10 |
| Dermal Sensitization | Under the conditions
of study, not a
sensitizer. | Under the conditions
of study, not a
sensitizer. | Same.
Both are tested to be
non-sensitizer. |
| | | | Under ISO 10993-10 |
| Cytotoxicity | Under the condition of
the study, the extract
from the device is
non- cytotoxic to L-
929 cells | Not available | The subject device
extract is non-
cytotoxic to L-929
cells under ISO
10993-5 |
5
Professional Latex Sdn Bhd
Lot 52, Jalan Logam 2, Kamunting Raya Industrial, 34600 Kamunting, Perak
6
Professional Latex Sdn Bhd
Lot 52, Jalan Logam 2, Kamunting Raya Industrial, 34600 Kamunting, Perak
7.0 Non-Clinical Performance Data
The performance test data of the non-clinical tests is reported in the table above.
8.0 Assessment of Clinical Performance Data
Not applicable - Clinical data is not needed.
9.0 Conclusion
From the non-clinical tests, it can be concluded that the Powder Free Latex Examination Glove, Non-Sterile, is as safe and as effective and performs as well or better than the legally marketed preeicate device.