(41 days)
Not Found
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI, ML, or any related technologies.
No
The device, a patient examination glove, is intended to prevent contamination between patient and examiner, not to treat, cure, mitigate, or prevent disease or affect the structure or function of the body.
No
Explanation: The device is an examination glove, which is used to prevent contamination, not to diagnose a medical condition.
No
The device is a physical examination glove, which is a hardware medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between a patient and an examiner by being worn on the examiner's hand. This is a physical barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: It's a glove, a physical barrier.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The device is clearly described as a physical barrier for protection, which falls under the category of medical devices but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
A patient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand 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
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)
Performance data is the same as mentioned immediately above. (Referring to technological characteristics like dimensions, length, palm width, thickness, and physical properties such as Tensile Strength and Ultimate Elongation).
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.
Not Found
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
PT. Haloni Jane
10,2
Jalan Raya Serang Km. 13,8 Cikupa – Tangerang Indonesia Ph. (+62-21) 596 2435 Fax (+62-21) 596 2436 Email halloni@telkom.net
"510 (K)" SUMMARY
| (1) Name of applicant
Address | : ANDY TANAKA
: PT. Haloni Jane
Jl. Raya Serang Km. 13.8
Cikupa - Tangerang
Indonesia
Phone No. : 62-61-5962435
Fax No. : 62-61-5962436 | NOV - 9 2006 |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact person in U.S.A | : Emmy Tjoeng
Phone No. : 909-591-8855
Fax No. : 909-628-6283 | |
| (2) Device details
Trade Name
Classification Name | : Powder free Latex Examination Gloves
: Powder free Latex Examination Gloves | |
| (3) Product Code | : 80 LYY | |
| (4) Equivalent device legally
marketed | : Class I Examination Gloves 80 LYY, Powder Free
meeting ASTM D 3578-05ae2 | |
| (5) Intended use | : Powder free Latex Examination gloves is a disposable device
intended for medical purpose that is worn on examiner's hand to
prevent contamination between patient and examiner. | |
1
PT. Haloni Jane
KOG2955
222
Jalan Raya Serang Km. 13,8 Cikupa – Tangerang Indonesia Ph. (+62-21) 596 2435 Fax (+62-21) 596 2436 Email haloni@telkom.net
| (6) Technological characteristic of the gloves. | ||||
|---|---|---|---|---|
| a. Dimensions | ||||
| Sizes | Small | Medium | Large | X-Large |
| Length mm (min.) | 240 | 240 | 240 | 240 $\pm$ 5 |
| Palm Width mm | 80 | 95 | 105 | 110 $\pm$ 10 |
| Thickness | ||||
| 1. Cuff mm (min) | 0.1 | 0.1 | 0.1 | 0.1 |
| 2. Palm mm(min) | 0.1 | 0.1 | 0.1 | 0.1 |
| 3. Finger Tip mm | 0.1 | 0.1 | 0.1 | 0.1 |
| b. Physical Properties | ||||
| Before ageing | After ageing | |||
| at 70°C 168 hrs. | ||||
| Tensile Strength | : 14 Mpa (min) | 14 Mpa (min) | ||
| Ultimate Elongation | : 500 % (min.) | 400 % (min.) |
(7) Performance data is the same as mentioned immediately above.
(8) Clinical data is not needed for gloves or for most devices cleared by the 510 (K) process.
(9) Non-clinical data
We certify that our final finished powder free latex examination gloves meet or exceed the ASTM D 3578-05ae2 Standard. Meets FDA pin hole requirement.
Meets labeling claim.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV ~ 9 2006
PT. Haloni Jane C/O Ms. Emmy Tjoeng Marketing Director Shamrock Marketing Company, Incorporated 5445 Daniels Street Chino, California 91710
Re: K062955
Trade/Device Name: Powder Free Latex Examination Gloves, Small, Medium, Large Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: October 26, 2006 Received: October 31, 2006
Dear Ms. Tjoeng:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 - Ms. Tjoeng
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807,97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Auy Sullom bor
Ching-Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
ANNEXURE II
INDICATION FOR USE
| Applicant | : PT. Haloni Jane |
|---|---|
| 510(k) Number (if known) | : K062955 |
| Device Name | : Powder Free Latex Examination Gloves |
| Indication for use | : |
A patient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR x (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shule A. Mighley 12
f Anesthesiology, General Hospital,
ion Control, Dental Devices
Number K062953