(134 days)
Not Found
Not Found
No
The 510(k) summary describes a medical glove and does not mention any AI or ML capabilities.
No.
The device is a glove intended to prevent contamination between a patient and examiner, not to treat a medical condition or ailment.
No
The device is described as a "disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner." This function is protective and falls under examination or barrier devices, not diagnostic. Diagnostic devices typically gather information about health conditions to aid in diagnosis.
No
The device is a physical examination glove, not a software application.
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 a glove worn on the hand to prevent contamination between patient and examiner. This is a barrier device for protection, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: While "Not Found" is listed, the intended use is the primary indicator.
- No mention of biological samples: There is no indication that this device interacts with or analyzes biological samples (blood, urine, tissue, etc.), which is a core characteristic of IVDs.
- Focus on barrier function: The description and performance studies focus on the glove's ability to prevent breakthrough of chemotherapy drugs, highlighting its barrier function.
Therefore, this device falls under the category of a medical device, specifically a protective barrier, rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Eudermic MP Powder-Free Latex Examination Glove (tested for use with chemotherapy drugs) 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, LZC
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
examiner's hand
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)
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Matt Clausen Regulatory Affairs Specialist Medline Industries, Incorporated One Medline Place Mundelein, Illinois 60060-4486
APR 2 1 2511
Re: K103602
Trade/Device Name: Eudermic MP Powder-Free Latex Examination Glove (Blue), Tested for Use with Chemotherapy Drugs, with a Protein Content Label Claim 240 min. |
| Etoposide (Toposar) | >240 min. |
| Cyclophosphamide (Cytoxan) | >240 min. |
| Carmustine | 6.26 min. |
| Thiotepa | 12.13 min. |
| Paclitaxel (Taxol) | >240 min. |
| Doxorubicin Hydrochloride | >240 min. |
| Dacarbazine (DTIC) | >240 min. |
| Cisplatin | >240 min. |
| Ifosfamide (Ifex) | >240 min. |
| Mitoxantrone | >240 min. |
| Vincristine Sulfate | >240 min. |
Please note that the following drugs have extremely low permeation times:
- Carmustine 6.26 minutes �
- Thiotepa 12.13 minutes .
(Division Sign-Off), Jours 2 2 mar 20 0 1 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 20 Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: = 103 602/500 2
Prescription Use (Part 21 CFR 801 Subpart D) OR
X Over-the-Counter Use (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)